Multinationals Geared Up Hiring For Regulatory Professionals

Many MNCs are on a hiring spree and are busy absorbing students for regulatory departments for CROs. Various international MNCs are cutting down their operations in foreign countries and expanding their business and workforce in India and moreover for their Indian operations they are endlessly recruiting for data management and regulatory affairs

Long considered a hub for regulatory clinical research by pharma multinationals because of quality,cost effective,English speaking workforce.Western countries which are majorly effected by the global meltdown has forced many MNCs to shut their shops in foreign countries and looking forward towards India as a place for opportunities .Along with multinational,many pharma majors and IT majors are also hiring.Stastics shows that India is the most favourable country.Recently India is leading to become most powerful and popular destination for regulatory clinical trials

In India not only clinical research but regulatory related clinical profiles is driving the employement sector. While drug majors are looking for the capable workforce,who can easily handle clinical data management and regulatory documents,which is quite a detailed procedures and moreover forms a part of research. Life sciences graduates are the most appropriate who understands glossary unlike in IT and banking.

National Bureau Of Agriculturally Important Microorganisms

Source :The Times Of India

Pharma Regulation & Clinical Trials Approvals Going e-governance

The concept of e-governance will likely to be launched and making the whole process quicker and simpler for pharma regulations and clinical trial approvals.













Source :The Economic Times

Bioinformatics Services

Inviting Tenders For Providing services For Bioinformatics Including Whole genome buffalo sequence SNP detection.

Source :The Times Of India

dear admin;

i have cleared all papers in APRIL 2008 for industrial programme in pharma regulatory affairs. i mailed you twice for original certficates. till now i didnt get them. pl do the needful and send me originals as i am leaving india shortly.

with regards

ramaraju srinivasarao

S07PRAF10094

BII active participation in Pharma Expo 2008

Bioinformatics Institute of India (BII) actively participated in 60th Indian Pharmaceutical Congress 2008 held at Netaji Subhas Institute of Technology, New Delhi from December 12 – 14, 2008.
The event was one of the largest events of pharmaceutical industry in India where more than 250 exhibitors took this opportunity to display their products & services. The event was attended by more than 8000 delegates including CEO’s , top executives of the pharmaceutical industry, R&D personnel, top officials of state & central agencies, academicians and teachers from medical and pharmacy colleges. There were huge networking & business opportunities for both exhibitors and delegates.

Bioinformatics Institute of India participated in the event with the objectives of creating awareness about various programs, trainings & services offered by the institution, to
interact with the medical and pharmacy students & to discuss business opportunities with Corporates. Mr. Vijay Shukla, Director BII and Dr. Kumud Sarin, Sr. Program Director BII were also present in the event BII along with the marketing and technical department of institution. All of them interacted very well with the students and officials from corporate to discuss the various training programs and services that can be taken up for the knowledge enhancement in the area of Bioinformatics, Pharma regulatory, clinical trials etc.

The event thus was quite successful and BII is looking forward to participate in much more events to follow in the pharmaceutical industry.

To view various programs & services offered by BII visit www.bii.in

For further details contact:
Bioinformatics Institute of India
C-56 A / 28, Sec – 62
Noida – 201301
U.P, India
Tel: 0120-4320801/02
9818473366, 9810535368
e-mail: info@bii.in
Web: www.bii.in

BII Active participation in Pharma Expo 2008

Bioinformatics Institute of India is actively participating in Pharma Expo 2008 which is going to held at Netaji Subhas Institute of Technology, Dwarka, New Delhi from December 12 – 14 2008.

The event is focussed on the pharmaceutical industry; more than 8000 delegates will attend the expo where 250 exhibitors are displaying their product & services.

The institute will take up this opportunity to display the various programs, trainings & services offered by them in the area of Bioinformatics, Pharma Regulatory, Clinical Trials etc.


To view various programs, training & services offered by BII visit: www.bii.in

Contact Bioinformatics Institute of India
Email: info@bii.in
Call: 9810535368, 9818473366

regarding assignments.............

thank you mam, for confirming about my asiignments..........

Indian Biotechnology Sector Is Thriving

Centralized Biotechnology Information System(BTISnet) is etablished by Govt. of India and inviting applications for Traineeship/Studentship in Bioinformatics

Source : The Times Of India

regarding the dispatch of assignments and research study

respected admin.
i am pursuing IIPR(Spring 2008)and my enrollment no. is S08IPPR10001.I had dispatched my assignments and research study to be eligible for the April 09 exams..................i just want to confirm whether it had reached u or not???????????kindly confirm it...i will be ever obliged for this!!!!!!!!!

Stringent Regulatory Norms For Medical Device Approval

The Indian Government may soon make it mandatory for medical devices such as stents,catheters,orthopedic implants and heart valves to obtain quality certifications before they reaches Indian medical device market.Products from both domestic and multinational medica device manufacturers must pass quality tests from standardizing bodies such as Bureau Of Indian Standards (BIS) or global quality solution provider Intertek

Leading players of medical device manufacturers such as siemens,Philips,GE and LG.India has a $2 billion medical device industry.The health ministry has asked Drug Controller General Of India (DCGI) to check marketing of forged and poor quality products.”The regulatory guidelines are ready and will be summitted it to the DTAB by the end of December for approvals.These guidelines would cover the definition,classification,certification and quality standards of medical devices.Whereas the standards are meant to test and verify medical devices,the classification will be in terms of risk associated with these devices.

The notified agencies would certify medical devices after auditing the quality,infrastructure,manpower and manufacturing plants of the company.The idea thus conceived to ensure access to safe,effective and clinically beneficial medical technologies for patients across the country

Certain medical devices are as important as life saving drugs;”There are devices which are implanted into human body for critical care.If not regulated patients may fall victim to poor quality medical devices.

Contact Information :DBT,Ministry Of Science And Biotechnology

E-mail address : swarup@dbt.nic.in

Website : www.dbtindia.nic.in

Source : The Economic Times

Dr. Bhavdeep's Corner

Visit my webpage
http://drbhavdeep.googlepages.com
Regards
Bhavdeep

Special Invitee For The Conference On Clinical Trials

Dr.Kumud Sarin - Sr. program director,BII was one of the distinguished invitee at the Inaugral session of seminar.She addressed the audience at inaugral session along with other dignitaries During session she presented the paper and was one of the penalist in the concluding session and concluded seminar by delivering the overview of seminar's outcomes and suggestion as addressed by the other speakers.

Source:The Economic Times

Regulatory Affairs :Recession Resistant

Clinical research organizations seems to be far away from global crunch as there is no near term impact of recession as major customers such as astrazeneca and glaxo continue to outsource more work to India.so India is getting more offshore work related to regulatory compliance and regulatory filing at one-fifth the US cost.

The $200-million regulatory affairs related Indian clinical research outsourcing market will escalate to $600 million by 2010,according to joint study done by research firm KPMG & CII.

India is the best destination for conducting global clinical trials because of faster enrollments,faster regulatory filings,speed up regulatory procedures.Eventually more man power is needed,so as to be at par with the increasing demand in this sector.Biopharmaceuticals companies are the key players with many major projects relating to regulatory clinical trials in pipeline.

Major players such as Biocon continue to get tremendous offshore work relating to regulatory clinical projects .”There is possibility that the global meltdown could mean a substantial increase in the revenues thus generated over the next few years.

Letter For Dr.Kumud Sarin : Senior Program Director

Dear Dr. Kumud Sarin Ji,

Sub: -Seminar on “Clinical Trials: The Heart of Medical Science” on 4th November 2008 at ASSOCHAM House, 47 Prithvi Raj Road, Opp. Safdarjung Tomb, New Delhi-110011

We are indeed thankful to you for the valuable time spared by you regarding your participation and excellent presentation in the above conference.

The participants appreciated your presentation which was very nicely presented by you and all of us benefited by the knowledge provided by you.

We thank you once again and look forward to your continued co-operation.

With kind regards,

Yours sincerely,

S. S. Chawla
Director (E & E),
Former Senior AdviserMinistry of Finance,
Govt. of India
Mob: -9810050681,
E-mail: s.s.chawla@assocham.com

Click here for presentation by Dr. Kumud Sarin-Sr. Program Director

Must Visit: CPhl India 2008

With India's pharmaceutical market growing at exponential rate, dodn't miss your chance to be one of the many visitors over 80 countries who benefit from this unique networking and buisness opportunity.

Visit : http://www.icsexpo.com,www.p-mec.com/

Dates and opening hours

Friday 28 November 10.00 - 18.00
Saturday 29 November 10.00 – 18.00
Sunday 30 November 10.00 - 1800

Please note that P-MEC will be open from 27-30 November

Venue Address
Bombay Exhibition Centre
Halls 5 and 6,
Western Express highway,
Goregaon
(East) Mumbai 400063,
India

Source:Indian Journal Of Experimental Biology

Source:The Hindustan Times

Letter for Dr Kumud Sarin : Senior Program Director

Dear Dr. Kumud Sarin Ji,

Sub: -Seminar on “Clinical Trials: The Heart of Medical Science” on 4th November 2008 at ASSOCHAM House, 47 Prithvi Raj Road, Opp. Safdarjung Tomb, New Delhi-110011

We are indeed thankful to you for the valuable time spared by you regarding your participation and excellent presentation in the above conference.

The participants appreciated your presentation which was very nicely presented by you and all of us benefited by the knowledge provided by you.

We thank you once again and look forward to your continued co-operation.

With kind regards,

Yours sincerely,





S. S. Chawla
Director (E & E),
Former Senior Adviser
Ministry of Finance, Govt. of India
Mob: -9810050681,
E-mail: s.s.chawla@assocham.com

Source:The Economic Times 05,Nov'08

Source:The Economic Times

Convention's Initiative:Update Professionals In Regulatory Agency

The FDA Class I Officers Association and Drugs Inspectors' Welfare Association, Maharashtra State, hosted the AIDCOC Convention 2008. The convention was an interactive platform to update professionals in regulatory agencies and pharmaceutical industry to share their views and distribution network about advances in the area of Pharmacotherapeutics. The theme 'Better healthcare through innovations in pharmaceuticals' was in line with AIDCOC's endeavour of achieving professional excellence through self-initiative and providing better services to the consumer. The program began with the keynote address on the theme by Dr Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon. The experts from various field shared their knowledge with the delegates on various subjects such as incentives to innovations through intellectual property rights, stem cell-emerging therapy, innovations in packaging, quality risk management, supply chain management and international regulatory harmonisation. Along with this, there was a panel discussion on 'Indian healthcare scenario-vision 2020' and 'Acquiring competitive edge through innovations'. Two hundred drugs control officers covering all states and two hundred professionals from pharmaceutical industry, blood banks, and clinical research organisations were registered as delegates.
AIDCOC Convention 2008 addressed key issues before the pharmaceutical industry and the concerns about the availability, affordability and rational use of medicines. It also focused on the benefits of innovations to the consumers and the need to concentrate resources and R&D efforts on specific disease pattern in India. S R Salunkhe, Organising Secretary and his team in the Organising Committee under the guidance of Dhanraj Khamatkar, Commissioner, FDA and Sandeep Bishnoi, Joint Commissioner, (Vig) as Patron and Co-Patron ensured the success of the event. The Organising Committee was guided and supported by SA Momin, Chairperson; Ravi Kant, President, AIDCOC; Ravi Uday Bhaskar, Secretary General, AIDCOC and S W Deshpande, Director General, AIDCOC. The conference brought together great emissaries from the field of pharma and biotech industry who shared their views on the current trends and needs of the industry.
Source:Express Pharma

ISCR Awards for Excellence in Clinical Research

Source: Biospectrum

The Indian Society for Clinical Research has instituted first ever awards for clinical research in India. The awards will promote meritorious work in the areas of clinical trials. “The ISCR Awards 2008” is India’s first industry-wide event exclusively for clinical research that aims to recognize the achievements and contributions to science and the advancement of drug research and healthcare. The event was celebrated in Mumbai, India on the October 16, 2008.

The Lifetime Achievement Award went to Dr A S Nanivadekar, a distinguished professional in medical & clinical research. Dr Narges Mahaluxmivala of Quintiles received the special Award “Notable Contribution to Clinical Research Fraternity” and Seth GS College & KEM Hospital, Mumbai received the other special award, “Notable Initiative to shape clinical research environment in India.”

Besides, there were four categories - CRA of the year, Study Manager of the year, Study coordinator of the year and Investigator of the year awards in which 8 winners received trophies and certificates - aimed at bringing wider recognition to the clinical research fraternity.

Nomination for the awards were invited from across the country that went through a rigorous review process by the jury panel consisting of Dr. Nilima Kshirsagar, Dr. S.M.Sapatnekar, Dr.Purvish M.Parikh and Dr Ferzaan N Engineer before selection of the winners.

Alliance:Between US FDA And Indian Drug Regulator

America’s Drug regulator US FDA is in talks with Indian drug regulator-The Drug Controller General Of India for co-operation on various regulatory parameters.

This alliance between Indian and American drug regulator reveals the global influence that Indian drug manufacture have.The world’s most stringent regulatory authority US FDA is in alliance plans with Drug Controller General Of India to work on most important issues considering drug investigative parameters.

More than 200 Indian drug units presently supplying generic category medicines to the Indian states which are already authorized by USFDA. Moreover Indian drug regulation is to be deeply understood by US regulator consequently better equipped US FDA will supervise Indian manufacturing units.

It furthers helps DCGI’S office in getting full exposure to current features of investigation, drug evaluation and approval processes.

USFDA is planning a risk evaluation and mitigation plans for several vital drugs globally in turn Indian drug regulators are being benefitted from such keen moves.

India as a base for Clinical Trials

Source: The Economic Times, 14th october'08

The investigational new drug (IND) filing process in the Indian regulatory system needs to change drastically to meet competitive challenges from China and Eastern Europe, geographies that are becoming powerhouses in clinical trials. India has made a mark in the low-end bio-equivalence testing for generic drugs, and western regulators are accepting Indian dossiers. It is, however, the more skill-based and high-tech process of doing phase I to III trials which are proving to be much more difficult.

In the past, Phase I trials were allowed only for Indian discovery molecules . This was done to stop Indians becoming “guinea pigs” for foreign companies. Phase II and onwards was allowed for other MNCs wanting to do a clinical study in India. Foreign companies did begin to do Phase 3 trials in India where this country became a part of the worldwide trials. Phase III and the other bio-equivalence work formed the bulk of the revenue of most of the CROs in India. India proved to be adept at following worldwide GCP (Good Clinical Practice ) methods and many scientists from abroad returned home to provide international methodology.

Bio-analytical work is also another lucrative technology process. Here, the Indian skill base is low and the cost of equipment is a few crores each. This kind of expensive equipment is not available in academic institutions and companies have to train fresh young recruits on these million-dollar machines. Eventually, the scientists are poached by other CROs and the cycle starts again. The government should start training bioanalytical scientists to fill this crucial and unmet need.

Recently, the drug regulator announced that the ban on Phase I studies by foreign companies is to be lifted . This makes eminent sense in the globalised world as it is becoming hard to determine what is “Indian.”
Many Indian companies may do parts of the research on foreign shores in their own subsidiaries and today’s NCE is being researched across the globe from Taiwan to Toronto. The expertise for approval of Phase I studies needs to be built whether the molecule is Indian or global.

The real hurdle is that the time taken to constitute the IND committee for a Phase I molecule is 6-8 months. From the time a proposal is made to the drug regulator, and it passes through the various health secretarial desks and an office order, it takes 6 months just for a committee to be formed. After this, the committee deliberates on the approval. In sharp contrast, the time taken for Phase I approval is just 28 days in Canada, Europe , the UK and other countries. India is lagging behind. At least 10 sitting committees must be formed by therapeutic areas (cardiology, oncology etc).

They can call on international skilled and experienced scientists to assist them. If we are to become the medicine maker to the world we must build world-class skills, quality and experience to provide affordable drugs not just for India but for the whole world. What is required is to ensure the key tenets of care, backed by solid, dynamic action, in turn rooted in deep knowledge. These are critical to the democratisation of healthcare and the reduction of disparities.

(The author is director, Piramal Healthcare)

INDIA CHEM 2008

Department of Chemicals & Petrochemicals, India & FICCI has organised 5th International Exhibition & Conference " INDIA CHEM 2008".
Following are the details for exhibition & conference:

Duration: October 20-22, 2008
Venue: Bombay Exhibition Centre, Mumbai

The exhibition and conference is inaugrated on 20th october, 2008 at Hotel Intercontinental The Grand, Mumbai

The exhibition and conference has 4 concurrent focussed shows:
* Chemicals
* Petrochemicals
* Pharmaceuticals
* Technologies, Process Plant Machinery, Control & Automation Systems

Highlights of INDIA CHEM 2008

Over 250 Companies expected to participate
Active participation from potential PCPIR states
Buyer - seller meet by chemexcil & Pharmexcil
Chemexcil Pavilion and REACH Registration Facility
Conclave of International Chemical Councils organized by ICC

for further details contact:
Manoj Mehta
Federation House
tansen Marg
New Delhi - 110001
Tel: 011 - 32910411
Mob: 9891098772
Email: manoj105@rediffmail.com

bioLOGIC India 2008: Global Biopharmaceutical Conference

Terrapinn (B2B media ) is organizing 6th Global biopharmaceutical conference on the growing biopharmaceutical sector in India . Following are the details about the conference:


Venue : Marriott Hyderabad, India
Dates: : 17th – 20th November, 2008

The conference is the platform where international and Indian biopharmaceutical industry leaders convene to discuss biopharmaceutical manufacturing trends, opportunities, best manufacturing & operational practices & methodologies and where:

• International biopharmaceutical manufacturers share their outsourcing and partnership needs, and discuss different partnership models

• Indian and international biopharmaceutical production gurus gather to discuss the best manufacturing practices and operational strategies to achieve higher efficiency and profitability

• Indian biotech and biopharma leaders showcase their newest biopharmaceutical innovation to international licensors and investors

• Indian CMOs to showcase their manufacturing capability and capacity to global outsourcing partners

For more information on the conference programme or to register contact:
Mr. Amit Singh
Tel: (65) 6322 2772
Fax: (65) 6223 3554
Email: amit.singh@terrapinn.com

DEAR ADMIN;

I HAV CLEARED ALL EXAMS IN APRIL , 2008. BUT, I HAV NOT RECEIVED CERTIFICATES . PL DO THE NEEDFUL.

WITH REGDS

DR.R.SRINIVASA RAO

S07 PRAF10094

INDUSTRAIL PROGRAMME IN PHARMA REGULATORY AFFAIRS

DEAR ADMIN;

I HAV CLEARED EXAMS HELD IN APRIL, 2008. BUT STILL, I HAVE NOT RECEIVED CERTIFICATES. PL DO THE NEEDFUL.

WITH REGDS
dr.r.srinivasa rao
S07 PRAF10094 industrial programme in pharma regulatory affairs

The Economic Times

BII At genzyme

BII organized a seminar for it's (Advance PG Programe in clinical trials,Research And Data Management) students at genzyme at its only facility at gurgoan.Purpose of seminar was to give exposure to a clinial research organization

Student's Feedback

• Session with Mr.himanshu was very constructive and helped us to get the insight of clinical trials and the management.
  
  .It was very interactive session cum presentation.
  
  We got to know lot about the prospects and application of clinical trials .We are looking forward for more such interactions with him.
  
  I,from the behalf of students of BII,NOIDA(Advance PG Programe in clinical trials,Research And Data Management) Thanks for such knowledgeable and interactive sessions with him.
  
  This was really a nice experience at genzyme.The Senior Programe coordinator of BII helps us a lot in having a full exposure of a clinical research organization

November 2008 Examinations

Dear Students of BII,

November 2008 examinations will be held on 8th and 9th November'08 i.e. Saturday and Sunday from 10 a.m to 2 p.m

Dispatching of Hall Tickets will begin from mid of October'08

For any query contact:
BII Support
0120-4320801/02
9818473366, 9810535368

All the Best for Examinations !

Why TO Join A Distance Participation Programe In Pharma Regulatory Affairs Only At BII ?

1. BII is regularly providing currently updated contents for its various modules in pharma regulatory affairs such as

· Pharma regulatory regime in US, EU and INDIA.
· Biomedical intellectual property management.
· Pharma regulation practices and procedures.
· Regulatory compliance for pharma and biotech products.
· Clinical trials and regulations.
· Good manufacturing practices,quality assurance and regulation.
· Reports on Indian patent law and pharmaceutical industry


2. Moreover the institute has its blog, BII blog. The Blog focuses and provides relevant and current news,technical and non technical articles and presentations whitepapers,various notification not only for pharma regulatory affairs but for its other regular and distance participation programe in clinical trials, bioinformatics any many more.


3. At BII students are supposed to write compulsory assingnments and research study. This exercise will enable them to think and innovate,so that they can grow and excel in the particular field.


4. One can view the representative list of our current and former pharma regulatory affairs students who are successfully placed and currently working at http://www.bii.in/

BII announces Admission Notice for forthcoming session of “Advance Program in Clinical Trials”

Who Heads the Global Regulatory Authorities ?

SELECTED DRUG REGULATORY AUTHORITIES
Title Of The Country’s Drug Regulatory Authority

INDIA	DCG(I) Center and State Drugs Controllers States
USA	FDA Commissioner
CANADA	Director General
BRAZIL	President Director
AUSTRALIA	Therapeutic Good Administration (TGA) Director
MALAYSIA	Director, Drug Control Authority
CHINA	Director-SDA
SOUTH AFRICA .	Registrar Medicines Control Council which is an independent body appointed by the Minister for Health
SOUTH KOREA	Director-Korea Food & Drugs Administration

dear admin;
i hav received email from you, informing me my marks . thanks for sending me email. but, when can i expect original certificate.
dr.r.srinivasa rao
S07 PRAF10094
industrail programme in pharma regulatory affairs

Sneha Diagnostics launches India's first Medical Diagnostics Blog

Sneha Diagnostics , the fastest growing medical diagnostic services provider in India, launches India's first Medical Diagnostics Blog http://www.diagnosticsblog.com

This blog brings you in a single location many useful Articles, news, trends, profiles and innovations in Medical Diagnostics (Radiology, Pathology, Clinical Laboratory), Preventive health care, Rural health care, Medical Tourism and other health care related areas (mainly from India ).

Since it's beta launch in December 2007, it has been attracting thousands of visitors across the globe who want to know more information in the above health related fields in India.

If you like to publish any diagnostics related articles /news, please send us: publish@diagnosticsblog.com


Sneha Diagnsotics

Prakasam Road, Near I.V.Palace
Governorpet, Vijayawada, AP, India
Tel: 91-866-244 1012 /244 1022
Fax: 91-866-244 1020

For more information about this blog, please send an email: info@diagnosticsblog.com

Visit http://www.snehadiagnostics.com to learn more about Sneha Diagnostics.

Global Conference on Clinical Research and Drug Development

Institute of Clinical Research (India) is organizing 5th Global Conference on Clinical Research and Drug Development. Following are the details about the conference:

Sponsored by : Department of Science and Technology, Government of India
Venue : Hotel Intercontinental The Grand, Mumbai
Dates: : October 10th & 11th, 2008


Contact for Registration:
Mr.Sameer Gupta, National Manager
Mobile no: +91- 9324610056
Email: sameergupta@icriindia.com


The conference will focus on recent advances and business opportunities in Clinical Research. About 400 delegates are expected to participate in the two-day event. The unique feature of this conference is that 10 International keynote speakers from US, Canada and UK along with highly acclaimed and eminent speakers of India from various Pharmaceutical Companies, CROs and Regulatory Bodies would be sharing their views and opinion in the conclave. The conference is designed for expert level professionals in the Pharmaceutical, Biotechnology, Medical Devices, Government, Support Services/Products, Academia, Logistics, Venture Capitalists, Bank, Insurance and related Healthcare Industries.

The conference could be attended by individuals involved in:
• Clinical Research and Development
• Clinical Safety and Pharmacovigilance
• Clinical Supply Operations
• Clinical Trial and Project Management
• Data Management
• Drug Development and Discovery
• Investigator Site Management
• Medical and Scientific Affairs
• Academia
• Outsourcing Management
• Contract Research Organizations
• Post-graduate Students Entering Pharmaceutical Industry
• Procurement and Purchasing
• Quality Assurance
• Regulatory Affairs
• Government and Public Policy; Lawmakers
• Senior and Executive-Level Decision Making for Clinical Trial

Regulatory Professionals :Goals and Roles

· Regulatory Affair Associate:
This profile is more about providing consultancy,where a person can play a lead role as a decision making considering all pros and cons.This type of role will suit people who enjoys taking tasks as a challenge, want additional responsibility, and enjoy the buzz and pressure of a dynamic environment.


Regulatory Affairs Assistants:
Providing administrative Regulatory support for timely delivery of products by assisting with technical support.
Prepration and submission of design dossier with approval body
Preprations for FDA and notified body inspection.
Assembly and submission of design dossier and technical document.


Quality Assurance Associate:
Again Pharmaceutical Quality Assurance professionals work as consultants

To provide audit and quality assurance services to ensure product success.
They play a vital role in developing pharmaceutical products that protect patient safety and ensure regulatory compliance.
By employing their vast skills and resources, professionals with their experience and knowledge to save money, minimize your risk and facilitate your project speed.

Quality Assurance Investigators

§ Professionals possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP's/ Change controls/ Deviations) as per various regulatory agencies.

§ Professional supports other member of regulatory teams in review and filing of various dossiers in US/EUROPE/CANADA/MCC/BRAZIL and various regulatory agencies across the globe.

§ Professionals Implements higher standard of quality in all areas of ANDA submissions for Tablets / Capsules /Dry Syrups/Oral solutions.

§ Professional assists in preparation of supplements, annual reports and amendments,Review of Stability data/Trends/Impurity profiles and perform various regulatory inspection.

• 
  Documentation Administrators
  Plan and organize internal and external meetings and teleconferences.
  Liaise with CROs, clinical sites, Clinical Investigators and others, as required
  Maintain paper-based and electronic files for Clinical and Regulatory departments
  Ability to develop and maintain indexing and filing system for Clinical and Regulatory documentation in line with regulatory requirements
  Receive, identify and file documentation in accordance with filing system.
  Generate listings of documents received and filed.
  
  Medical Information Associate:
  
  Professionals will be involved in setting up new global processes and systems to align all affiliates & distributors for medical information.
  
  Professionals act as the key point of contact for medical information enquiries locally & from international affiliates.
  
  Professionals are Responsible for composing written & verbal responses to internal and external customers.
  
  They are also responsible Literature searches & literature reviews and updating medical information database.
  
  
  
  
  
  
  

Job opportunities at Sneha Diagnostics

Please visit our career link: http://www.snehadiagnostics.com/existingopenings for various openings

Please send your resume to : hr@snehadiagnsotics.com

Source:The Economic Times

.

Source:The Economic Times

Sneha Diagnostics will soon open world class medical diagnostic center in Vijayawada, AP, India

Sneha Diagnostics will be soon opening a new world class medical diagnostics centre in Vijayawada,AP,India.

We're looking for well experienced medical consultants (all specializations ) to join full-time /part-time (flexible hours ) basis at our Vijayawada centre.

Please send your detailed resume to : hr@snehadiagnostics.com

Sneha Diagnostics

Prakasam Road, Near I.V.Palace
Governorpet, Vijayawada, AP, India

Tel: 91-866-244 1012 /244 1022
Fax: 91-866-244 1020

Email: vja@snehadiagnostics.com

http://www.snehadiagnostics.com/

Presentation On CV Making

Source:HT,Wednesday,september 10,2008

Source: HT,Wednesday,September 10,2008

Regulatory Affairs :Future Of Professionals

As Pharmaceutical Industry is confronting a stiff competition and escalating towards growth and the same sector is experiencing growth opppurtunities. As society is maturing,more attention is being paid to the areas relating to new drug development and health care improvements so that the end users can get quality health care services.

As mentioned earlier not only pharmaceuticals but medical device and biotechnology industry are experiencing invariable growth stimulated by growing market opportunities and advancement in the field of biology and technology .Development of new therapeutics and diagnostics consequently creating tremendous job opportunities in regulatory and clinical research sector.

Biopharmaceutical industry is facing increase in demand in terms of quality of research and development consequently experiencing a positive impact on job market.This sector is currently seeing shortage of well versed and skilled professionals and moreover professionals are entering indirectly in this sector.By and large professionals learn more about requirements from their partners,various publications,latest developments and amendments in the regulatory sector.

Again experience matters a lot relative to academic qualification, this is due to the fact that professionals who are working in professional environment and students who have just completed their academic qualification and want to switch over to job can bring in the discontinuity in between completing academic qualification and searching for a regular employement.

Current regulatory affairs professionals are keen to prepare regulatory affairs professional by volunteering and highlighting the challenges and upcoming opportunities for their colleagues with in their organization and imparting academic and professional knowledge for becoming next generation regulatory affair professional

Tripping Into Regulatory Affairs...and Glad to Be Here

Preventive Healthcare Seminar organized at BII Noida

A seminar on “Preventive Healthcare” was organized at BII Noida on 4th sept’08 by Kailash Hospital. The seminar was attended by the Program Director, faculty, students & other staff members of BII

















Mr.Sankalp Bansal, Chief Operating Officer from Kailash Healthcare Ltd provided with some vital information on:

• Rising health issues in India
• Importance of regular health check ups and
• Key preventions one should take up in order to live a healthy, disease-free life.


The seminar was quite informative and was appreciated by one and all.

10 Facts: Why I Want to Become Regulatory Affairs Professional

I. Most rewarding,future secured,challenging and one of the highly paying career in its class.

II. Most interesting and employee friendly environment in companies to work for.

III. Tremendous job opportunities are created day by day in this particular sector.

IV. Relatively Excellent opportunities for those with medical and life sciences background.

V. Professionals drawing handsome salaries as compared to their peers in other areas of pharmaceutical and biotechnological industry.

VI. Many countries still facing dearth of regulatory affairs professional including India and Japan. SOURCE:http://www.heidrick.com.

VII. Professionals with Regulatory affairs certification had an edge over others and moreover these professionals are preferred while hiring.

VIII. Jobs and nature of work employed in this sector is considered as respectable.

IX. Professionals working as regulatory trainee can get frequent promotions definitely based on their performance as compared to their counterparts in various sectors.

X. Working professionals can easily get into this profession by simply joining a Distance Participation Progame In Pharma Regulatory Affairs.

hai

when can we expect certificates of partcipants, who have cleared exams in april, 2008

dr.r.srinivasa rao
s07praf10094
industrail programme in pharma regulatory affairs

REGULATORY AFFAIRS: ETERNAL LEARNING

If you talk about regulatory affair ,many budding scientists dodn’t know what regulatory affairs profession is ? The reason behind the lack of awareness among scientists is that collection of advanced regulatory affair programe are not designed keeping in mind the science curriculam.Still the regulatory affair profession is most rich and rewarding career.

According to RAPS(Regulatory affair professional society):The regulatory field is more concerned about making, approving safe and effective healthcare product worldwide.But this indefinite description fails to show the true side of this profession.

Working professionals have similar views considering regulatory careers,though they are working on dissimilar aspect of regulatory affair.In addition regulatory scientist unquestionably believes that knowledge of regulatory rules,policies,laws and strategies requires no formal training.Those who have entered this profession with core science background have a systematic approach and impart their knowledge.

It is never ending process of regulatory learning and the professionals have to keep themselves updated in terms of both current scientific and general regulatory development,the thing which is to be appreciated about this career.Again to excel and to make a mark in regulatory career is to keep yourself,the first to be informed about the latest regulatory developments.The most interesting thing about this profession and career is that professionals can learn more and more about latest development in regulatory sector.

Regulatory affairs department is relatively flexible among those employed in different sectors with science background and the scientific skills needed are similar to their counterparts.Regulatory affairs is the most future secured,highly successful and satisfying career.Professionls employed believes that scientific knowledge,regulatory,communication skills and the desire to know and grow makes this profession a lifetime of learning.

For Careers In Regulatory Affairs and Current Regulatory Articles,Regularly Go Through The Blog And Last Date Of Application For Industry Programe In Pharma Regulatory Affairs Is 15 SEPTEMBER 2008.

Regulatory Professionals:Pivotal For Pharmaceutical

The Article provides information on how regulatory affair professionals acts as a backbone for pharmaceuticals,biologics,medical device industry. Professionals employed in this sector participate at each level of drug development, clinical trial application,post market surveillance.The procedure includes filling application for the safety and efficacy of a drug which is yet to get market approvals before regulatory authorities like DCA,CDSCO and finally have to get U.S FDA approvals.

Apart from visiting and contacting regulatory authorities for final market approvals.Sometimes they have to contact or coordinate timely with their in house team for timely market approvals,for a drug to make final presence in market. It is the responsibility of regulatory professional to get timely market approvals, somehow if market approvals got delayed,the organization have to bear financial losses.

There are Regulatory experts who provide regulatory advice to pharmaceuticals ,biologics,medical device and food industry to assure compliance with various regulatory authorities.They conduct audit of pharmaceutical manufacturing facilities and their suppliers and check for their compliance with FDA regulation and principles.Further they conduct audit of clinical investigator.They also assist in prepration and review of regulatory submission to FDA including Investigational New Drug Application(INDs),Abbreviated New Drug Application(ANDA),New Drug Application(NDAs) and Clinical Trial Application(CTAs)

Indian Regulatory System:Destination For Global Clinical Trials

Bringing and developing Regulatory Affairs profession in Indian pharma industry is initiative of Indian government in the interest of public health,by controlling and checking the strength,efficacy,purity,safety of pharmaceuticals,veterinary products,cosmetics,so as to deliver a quality product in Indian market.Regulatory Affairs is the one of the most regulated department in pharmaceuticals,biotechnology,medical devices industries and above all in clinical research organization(CROs).
Indian Pharma majors are confronting a stiff competition among themselves and all the major companies are eyeing India as one of the best destination for research and development investments.Again Indian government and various health regulatory bodies playing a pivotal role and taking tremendous steps to showcase India as the best destination for conducting their clinical trials.Since the cost for conducting clinical trials is one-fifth relatively to other countries.
In India there are many hospitals engaged for conducting clinical trials with ICH-GCP trained investigators.Due to the latest advancement in the technology,many MNCs are keen to allow phase-1 clinical trials for the molecules discovered abroad.

MNCs who did not choosen India earlier due to lack of global regulatory guidelnes are now approaching India because India has released it’s guidelines on global clinical trials. India now is a TRIPS compliant and already it had entered into product patent system in 2005.
Necessary action will be taken against those pharma companies which do not comply with schedule M and against counterfeit drug manufacture so they have to face dire consequences like life imprisonment and heavy penalties.

Due to advancement in Indian regulatory system,its rapidly gaining the attention of different countries,as india will be the future destination for global clinical trials.

Presentation On Group Discussion

Effective Communication Skills

BECOME A FREE LANCER REGULATORY AFFAIRS CONSULTANT

Regulatory Affairs is a great and ever increasing career which happened to be in pharmaceutical industry and the profession is most rewarding and lucrative.The profession creates numerous opportunities not only as a regulatory professional in industry but also a freelancer consultant.

Who is a Freelancer regulatory consultant ?

A freelancer regulatory consultant works for national and offshore pharmaceutical company or sometimes they have to work for a short period with their In-house regulatory team.

Freelancer regulatory consultants need to contact medical and regulatory agencies for early approvals and prepare documents showing efficacy and safety of indications as a part of their work

What are the Possibilities for career in future ?

To become a regulatory consultant one should have sound knowledge background and above all should be well versed with the regulatory environment and regulatory skills.One can start his/her career as a regulatory consultant business.

Important skills for someone to become a regulatory consultants ?
One should have critical ability to translate intricate terms and content into more simpler and precise manner which is easier to understand.

One can convince assessors and their clients that you have a right approach and views.

One should have regulatory skills while contacting and meeting healthcare regulatory agencies.

Go for it! Ways of working for Pharmaceuticals varies from industry to industry and Scope of opportunities in this sector are great.

For Careers And Job Oppurtunities In Regulatory Affairs Read More Updates And Relevant News On Blog

dear admin,
received my certificate and mark sheet for the Industry program in clinical trials, research and administration for Spring Batch 2007.

Thanking you
Anjuli Barai

Bioinformatics Institute of India, BII organized an Induction Program for “Advance Program in Clinical Trial, Research & data Management” on Sunday, 10th august, 08 at Rai’s Party Lounge, Shopprex Mall, Noida.

The Program was attended by BII Director, Program Director, Faculty, administrative member & Students of Clinical Trial Program

The Program started with the presentation of Dr.Kumud Sarin, Program Director of BII. She addressed the students with entire program overview of “Advance Program in Clinical Trial, Research & Data Management” She introduced the students with the various visiting faculty from industry & academia and also interacted with the students very well related to all their queries regarding the Program. Her presentation covered the Basic Program Details, Program curriculum, introduction of various faculties & Clinical Trial introduction.Afterwards, Dr. Neena Valecha, Scientist (E) of Malaria Research Centre ICMR educates the students about various career opportunities that exist in the field of Clinical Trial, Research & Data Management. She also informed the students about various Good Clinical Practices being designed by ICMR.

Another Program faculty, Mr. Asif Khan, an expert in SAS Programming explained the students about Clinical Data Management & Role of IT in Clinical Trials.

Mr.G.K Srivastava, Clinical Trial Coordinator with a leading hospital, is another faculty for the Program. He interacted with students regarding the Clinical Trial Project Management. He discussed the various opportunities & challenges in the area of Clinical Trial Project Management.

Each of the faculty interacted very well with students & explained them about the various opportunities in this growing field of Clinical Trials. The induction program organized by BII was very successful and was appreciated by one and all.

Regulatory Affairs Professional In A Outsourcing Buisness

Regulatory Affairs department plays a pivotal role in driving the R&D efforts of the company to the market.It takes a lot of time for a product to make its final presence in the market.And Its the regulatory affairs department which is responsible for getting timely market approvals.Delay in getting market approvals can effect the market share and revenue thus generated. And the only success lies for the pharmaceuticals is timely market approvals from regulators.

So to get the timely approvals,the pharmaceuticals either should have a regulatory departmennt with strong regulatory knowledge or they should get all the approvals outsourced through regulatory consulting firms.

In Today's scenario,with changing global regulatory norms.Outsourcing regulatory work seems to be beneficial and less time consuming rather than making a large regulatory department which is time consuming and is expensive.And the consultants needs to update their knowledge in current regulation, so as to make the approval process less time consuming.

There are many regulatory consulting firms which outsource regulatory work both at large scale and small scale. Outsourcing regulatory work depends upon core competencies which varies from outsorcing firm to firm and on the quality of work provided by a outsourcing firm which in turn depends on the regulatory affairs professionals employed.Regulatory firm hired by the customer company can surely expedite the regulatory approval process if the customer company shows the active participation.

For Career In Regulatory Affairs,Read Daily Updates And Relevant News On Blog

Bioinformatics Institute Of India

CLINICAL DATA MANAGEMENT-SYSTEM & SOFTWARES

CLINICAL TRIALS REGISTRY-AN INSIGHT

Regulatory Affairs Profession And Skills Are Coveted

Of all the medical industry professions revealing salary growth and providing strong and quick opportunities, regulatory affairs professionals are doing particularly well than their peers. Among respondents to the MD&DI survey, those in regulatory and legal affairs earning handsome than their counterparts except general and corporate management.A study conducted by RAPS(RAPS; Rockville, MD) reveals that Among other trends, it showed that base salaries for U.S. regulatory professionals rose 9.8% from 2003 to 2006, compared with 7.6% for peers over the same time period. The publicly released portion of the study does not isolate device professionals from those in other FDA-regulated industries, but a RAPS spokesperson says that there is virtually no difference among the industries. Trends over the past 10–12 years, shows tremendous scope of practise.Regulatory Affairs professionals are working not only on multiple product lines, but also that they have greater involvement through the preclinical, clinical and postmarket surveillance stages.Regulatory professionals with knowledge and regulatory skills plays a vital role in organization in designing regulatory strategies,resulting in positive salary trends and the same trend applies to those in the clinical field.Regulatory and clinical professions are in demand and getting numerous lucrative offers. Reason behind this is that the candidates dodn’t change organizations often.Professionals who are well versed in clinical trials and regulatory functions particularly with profiles related to PMA track devices especially implantables are highly desired by MNC organization.Substantial growth has been seen within organization involved with the development of new implantables therapies to treat cardiovascular and neurological disorders

For Careers In Regulatory Affairs, Read Daily Updates And Relevant News On Blog

The Dearth Of Regulatory Affairs People In Japan

The Shortage Of Good Regulatory Affairs People In Japan Is A Major Headache For Pharmaceuticals And Medical Devices Firms.

• The work involves a blend of medical expertise and an intimate understanding of Japanese regulation and the vast bureaucracy of the MHLW. A good regulatory affairs executive knows where to take risks, as well as where the regulator will give ground – and where it will not.
• Regulatory affairs professionals tend to enjoy technical challenges, and their job only remains interesting if they are constantly challenged with new products.
• Relationships are of critical importance in Japanese culture; if a regulatory affairs executive lacks relationships at headquarters, it may be difficult for them to speak up or they may start to look outside.

SOURCE:http://www.heidrick.com

Job Search For Regulatory Affairs Professionals Has Got Quicker And Easier

For All Regulatory Affairs Professionals,Follow The Tips And The Job Is Yours.

JOB HUNTING TIPS
Keeping an eye open to opportunities makes a lot of sense in today's business world. Profit/loss, Wall Street and consumer demand all have an impact on today's businesses. And ultimately, that impact plays havoc with people's lives. The Pharmaceutical industry is a segment of the economy where stability is something that is often taken for granted. So, keep an eye open.
Watching the job market in the industry is really a simple task. The best way is to maintain contact with former co-workers and supervisors. A call once every 6 months or so, a card for the holidays or an email can pay off down the road when you might need to contact someone from years past. It is also a way to listen to the pulse of the industry. Everyone receives calls from Head Hunters; sometimes two or 3 a day. Listen closely and keep your resume up to date.

GETTING ACTIVE
Your first task (because you've always kept your resume updated) is to start a "Job Diary". Any time you send out a resume, log it by date, recipient and response. If you decide to work with a recruiter, make absolutely sure that they are not to send out your resume without your express approval for a specific role. You don't want your resume "hanging in the wind". There have been all too many times when we have made contact with a client and made a presentation about a specific candidate, only to find out that the candidate has already been submitted. At that point, the candidate might never have existed, because no company will put themselves in a position where they might be liable for two fees.

RESUMES
If a resume is simply a long list of tasks and accomplishments, the 15 seconds or so that might be spent on an initial review will never have the desired result: an interview. Build your resume from the Top Down; in other words, summarize your career with a few sentences at the top, then explain your roles in the light they deserve. Make sure that your summary tells readers why you are qualified for the role; then show them

Neuland requires Deputy Manager-Regulatory Affairs (APIs)

About the position : Position reports to Senior Manager-Regulatory Affairs and is based out of the manufacturing location near Hyderabad.

Expected Candidate Profile : Masters in Chemistry or PhD in Chemistry with 5 to 7 years of experience in RA function with API/Bulk Drug manufacturing companies having customers from the regulated markets.

How to apply : Interested persons may please send their resumes to careers@neulandlabs.com.

About Neuland :

Neuland (Laboratories Limited) is a quality conscious and research driven, reliable Active Pharmaceutical Ingredients manufacturing company, specializing in Contract Research and Manufacturing. (In business) since 23 years, Neuland is a preferred source for all the major generic companies across the globe. Neuland, a $50 Million company, having the largest market share of Ciprofloxacin Hcl in US & Europe has close to 25 products across 8 different therapeutic segments in our portfolio.
Neuland's multi-product manufacturing facilities at Bonthapally and Pashamylaram (close to Hyderabad) are inspected and approved by USFDA and both the units also boast GMP approval from TGA, Australia. Neuland has been accredited with COS from EDQM for Eight of its API's across four therapeutic categories. Neuland services more than 800 customers spread across 80 countries.
Neuland with 27 USDMF's and more than 305 DMF filings with various Health Authorities across Europe and other regulated markets is testimony enough to Neuland's unrelenting commitment for being and continuing to be a preferred source worldwide.

Job Openings

Source:Times Ascent, 30 July'08

Tremendous Oppurtunities For Engineers In Regulatory Affairs Sector

What Are Some Of The Essential Roles And Responsiblities Of Regulatory Affair Engineers ?

Responsibilities:
Regulatory Affairs inputs for Risk Management Files, Compliance Plan and design requirements for safety (safety standards).

Work to continually improve operating excellence with regards to process execution.

Provide support during internal and external audits of the GEHC Quality Management System within respected areas.

Roles:

For supporting the global regulatory submissions which include maintaining and implementing the company's regulatory affairs systems.

-Supporting all global regulatory submissions

-Authoring global regulatory submissions

-Conducting training to other employees on regulatory matters

-Assisting with the reclassification process

-Developing, implementing and maintaining regulatory standard operating procedures

JOB SUMMARY: The Quality Assurance and Regulatory Affairs Engineer is responsible for the complete QA/RA responsibilities throughout the enterprise (Marketing, Sales/Service, Supplier, R&D, Manufacturing and Customer.)

Clinical Trials And Drug Discovery Are The Major Areas Of Expansion And Interest

SOURCE:The Economic Times 25 July'08

DUAL PROGRAM IN BIOINFORMATICS - JOIN NOW

INDUSTRY PROGRAM IN PHARMA REGULATORY AFFAIRS-JOIN NOW

Dear Admin,
please can we know when the results of April2008 of Spring batch2007 will be published?

Regulatory Framework:SOPs For Ethical Regulation Of Drugs

EXTENTION OF SUBMISSION PERIOD

Dear co-ordinator,

I would like to know whether the submission period for assignment and research paper would be extended for autumn,07 batch of IPPRA.

Please reply,

with regards,

RAM KUMAR.S

Telemedicine

Diverse World Of Regulatory Affairs Professionals

This Article will focus on the Prominent Aspects of Regulatory Affairs(RA) Professionals and the opportunities open to RA professionals as they begin and Excel in their careers.We hope that it will help those readers with more experience when encouraging young professionals/graduates to explore what can be a lifelong and secure career.All functions with in the pharmaceutical,Biomedical,CRO's carry their own level of priority considering the Nature and Importance of work,but it is the regulatory affairs that Escalate.Diverse Field and Regulatory Related Roles of RA Professional as shown in the Figure are Crucial to the Industry.It is the RA Professional which Acts as a Backbone for the Industry.Professionals employed in this sector Interacts with the other Professionals Through out the Industry. Working at a Base Level in regulatory Sector will help professionals learn more and helps in improving Regulatory skills. As your Knowledge and Exprience grows you will become easily involved in strategic developement plans.Your Advice and Regulatory expertise become an integral part of regulatory Strategies.
However For Those of you who are considering RA as a career move,that Apart From various Pharmaceutical,biotechnolgy sector,the major mushrooming sector for RA Professional are the CRO's and consultancy area where many people begin their RA career. With the opportunity to work on a wide variety of projects with numerous companies, it is often commented that the experience you gain in these organisations in two months can be worth two years in a specialist department of a large pharmaceutical company.
So for those of you holding valueable medical and para medical degrees and still not getting a career start.This is the Time to Grab the oppurtunity for those who really want to make Regulatory Affair as a career.