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Chapter - 12 Need For The Introduction of Regulatory Affairs in The Pharmacy Curriculum
Chapter - 12 Need For The Introduction of Regulatory Affairs in The Pharmacy Curriculum
Chapter - 12 Need For The Introduction of Regulatory Affairs in The Pharmacy Curriculum
CHAPTER - 12
NEED FOR THE INTRODUCTION OF REGULATORY AFFAIRS
IN THE PHARMACY CURRICULUM
D. Sreedhar, G.Subramanian, M. Sreenivasa Reddy and N.Udupa .
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In general, the curriculum comprises of professionals working in the area of regulatory
introductory foundation that outlines the health care affairs grow and keep learning. The professional
product research, development process and the will be trained regarding what he is supposed to do
regulatory oversight of the complex processes. soon after he joins industry unlike the conventional
There are both part-time and full-time courses way of undergoing training under a qualified
available for the subject. Part-time courses are regulatory practitioner right after joining the job. This
suitable for the professional who will come across step will definitely ignite the power of knowledge in
these terms occasionally where as full-time course the professionals and make them accustomed with
is meant for the professional who intends to make the working environment.
his career in the regulatory affairs3 The course
material is also available in the from of online, The recent trend is that the MNCs abroad are
distance learning and interactive CDs mode. looking forward to India as their preferred destination
for the drug development and research activities. It
Regulatory affairs position is in highest demand gives more weightage to the need of expertise in
and fastest growing according to the findings from the field of regulatory affairs in the post-GATT
a recent survey on employment trends in the clinical implementation age.
trials industry from CenterWatch4, the reasons
being the lack of candidates who wish to make their References
career in this field and increasing turnover of the
pharmaceutical industries. 1. www.fda.gov|
Pharmaceutical Regulatory affairs is a vast 2. “Training Needs in Regulatory Science for the
area, which cannot be taught just with the help of Biopharmaceutical Industry,” Naturejobs
books or the course materials. The issues related Biotechnology vol.19 (12) p.1187-1188,
to the field are often updated so the professionals December 2001.
find it challenging to keep abreast with the recent 3. “Careers in Regulatory Affairs from Practitioner
modifications and inclusions. to professional,” Naturejobs Biotechnology,
vol.20(4), p 409-410 April 2002
Conclusion
4. www.centerwatch. com|
Incorporating regulatory affairs into the
pharmacy curriculum will make the pharmaceutical
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