Regulatory Affairs Professional Development Framework

Regulatory affairs (RA) professionals play critical roles throughout the healthcare product lifecycle, from concept through product obsolescence. They provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world. Continuous evolution in science and changes in the regulatory environment, health sector and general economics shape the dynamic and expanding scope of the regulatory affairs professional. Regulatory Affairs professionals must continually grow their knowledge and skills to be effective and to advance in their profession.The Regulatory Affairs Professionals Society (RAPS) was established in 1976 with a mission of creating the foundation for developing and nurturing the emerging healthcare product regulatory affairs profession. A key building block of establishing Regulatory Affairs as a profession was put into place in 1990 when RAPS introduced a professional certification, the Regulatory Affairs Certification (RAC). The development of the RAC was based upon extensive research on the scope of practice and specific activities of the professional with three to five years of regulatory experience, the target for this professional credential. This research has been replicated and updated several times, with studies extended to professionals involved with the European, US and Canadian regulatory systems.The role delineation research indicated the unique knowledge base of the profession, which extends through the healthcare product lifecycle and blends content from the sciences, law and business. These studies also indicated consistency in the general scope of responsibilities of the professionals at this level, distinct from geographic location.However, these studies focused on only one level of the profession. The RA profession today encompasses multiple levels, from the professional at entry level through the highly experienced professional with extensive technical knowledge and management responsibilities.
The PD Framework provides a general model for describing the Regulatory Affairs profession at the four career stages delineated in this project. For each level, the framework presents tasks and responsibilities organized according to the stages and steps in the healthcare product lifecycle as well as the associated knowledge and skills required by the professional.

Source : Regulatory Affairs Professional Society

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