Regulation Affairs in Biotechnology detailed syllabus for Biotechnology & Biochemical Engineering (BBE) for 2021 regulation curriculum has been taken from the Anna Universities official website and presented for the BBE students. For course code, course name, number of credits for a course and other scheme related information, do visit full semester subjects post given below.
For Biotechnology & Biochemical Engineering 6th Sem scheme and its subjects, do visit BBE 6th Sem 2021 regulation scheme. For Professional Elective-V scheme and its subjects refer to BBE Professional Elective-V syllabus scheme. The detailed syllabus of regulation affairs in biotechnology is as follows.
Course Objectives:
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Unit I
REGULATIONS GOVERNING CLINICAL TRIALS 9
Clinical Research regulations in India – CDSCO guidelines, ICMR guidelines, Clinical trial application requirements in India- IND, ANDA, AADA and NDA., USFDA regulations to conduct drug studies, Clinical Research regulations in UK – Medicines and Healthcare Products Regulatory Agency (MHRA) ,Clinical Research regulations in Europe (EMEA).
Unit II
REGULATORY REQUIREMENTS IN PHARMACEUTICAL INDUSTRIES 9
Pharmaceuticals: Bulk drug manufacture; Practice of cGMP,Personnel, Drugs and Cosmetics Act 1940 and Rules 1945: DPCO and NPPA, Buildings and Facilities, Process Equipment, Documentation and Records, -Materials Management, Production and In-Process Controls, Packaging and Identification Labelling of API’s and Intermediates, Storage and distribution, -Biotechnology derived products; Principles, Personnel, Premises and equipments, Animal quarters and care, production, labelling, Lot processing records and distribution records, quality assurance and quality control.
Unit III
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Unit IV
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS 9
History of Food and Nutraceutical Regulations, Food Safety and Standards Act, Food Safety and Standards Authority of India: Organization and Functions, Regulations for import, manufacture and sale of nutraceutical products in India, Recommended Dietary Allowances (RDA) in India, US FDA Food Safety Modernization Act, Dietary Supplement Health and Education Act. U.S. regulations for manufacture and sale of nutraceuticals and dietary supplements, Labelling Requirements and Label Claims for Dietary Supplements, Recommended Dietary Allowances (RDA) in the U.S, European Food Safety Authority (EFSA): Organization and Functions. EU Directives and regulations for manufacture and sale of nutraceuticals and dietary supplements. Nutrition labelling.
Unit V
REGULATORY ASPECTS IN BIOLOGICS AND DIAGNOSTICS 9
Introduction to Biologics; biologics, biological and biosimilars, scientific guidelines and guidance related to biologics in EU, comparability/ biosimilarity assessment, Plasma master file, TSE/ BSE evaluation, development and regulatory approval of biologics, Blood and Blood Products Regulations in India, US and European Union.
Course Outcomes:
Upon completion of the course,
- The student shall be able to know harmonization initiatives for approval and marketing of medical devices
- Quality considerations clinical evaluation and investigation of medical devices and IVDs
- Regulatory approval process for medical devices and IVDs in India, US, Canada, EU, Japan and ASEAN and IVDs
Text Books:
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Reference Books:
- N Udupa,Krishnamurthy Bhat, A Concise Textbook of Drug Regulatory Affairs, Manipal University Press (MUP); First Edition, 2015.
For detailed syllabus of all the other subjects of Biotechnology & Biochemical Engineering 6th Sem, visit BBE 6th Sem subject syllabuses for 2021 regulation.
For all Biotechnology & Biochemical Engineering results, visit Anna University BBE all semester results direct link.