JNTUH M.Pharm 2017-2018 (R17) Detailed Syllabus Regulatory submissions: Drugs, Biologicals and Medical devices

Regulatory submissions: Drugs, Biologicals and Medical devices Detailed Syllabus for Quality Assurance and Pharma Regulatory Affairs  M.Pharm first year second sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.

The detailed syllabus for Regulatory submissions: Drugs, Biologicals and Medical devices M.Pharm 2017-2018 (R17) first year second sem is as follows.

M.Pharm. I Year II Sem.

Course Objective: This subject gives the details about the regulatory aspect for development of new drugs according to global agencies like USA, UK, and India. This subject provides the information about process for global pharmaceutical product approvals .Which give the guidance on preparation & submission of electronic documents CTD.

Course Outcome: Students prefer the collections &organizations regulatory package for development of drugs to global agencies IND .Students get the guidelines for preclinical testing & clinical testing in E.U. Regulatory considerations for manufacturing, packaging & labelling of pharmaceuticals in E.U. They will learn the about the annual reports post approval changes.

UNIT I : Overview of regulations pharmaceutical products

1. Drugs (new and generic)
2. Biologics (new and biosimilars)
3. Medical devices
4. Combination products examples : drug-drug and drug-device

Overview of regulations (FDA, ICH, EMA, WHO) for drugs

1. New drugs
2. Generic drugs
3. Orphan drugs

UNIT II : Overview of regulations for biologics

1. Newly developed biologics
2. Biosimilars

Overview of regulations for medical devices

1. Classifications
2. Exemptions
3. Approval process – premarket approval (PMA) or premarket notification (510k)

UNIT III : Collecting and organizing regulatory package for development of new drugs to global agencies:
Investigational New Drug Application (IND), Investigational Medicinal Product Dossier (IMPD), Investigator’s Brochure (IB)
Collecting and organizing regulatory package for approval of new drugs to global agencies. New Drug Applications for Global Pharmaceutical Product Approvals (NDA, BLA), Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs) and Pre-Market Approvals (PMAs) and notifications (510k).

UNIT IV : Common Technical Document (CTD)
Preparation and submission of electronic documents: The CTD and eCTD. Drug regulatory authorities in European Union (EU) with special reference to EMA and UKMHRA: Introduction, Organization and General Guidelines. Regulatory consideration for pre-clinical testing and clinical testing in EU, types of filing process (centralized, de- centralized, RMS countries), SPCs, SPC exclusivities, Registration application for marketing approval in EU, Common Technical Document and Drug Master Files, in EU, Factory Inspection. Regulatory considerations for manufacturing, packaging and, labeling of pharmaceuticals in EU.

UNIT V : Post-market regulatory obligations
Responsibilities and reporting of annual reports, post approval changes, post approval clinical studies and managing the outcomes.

TEXT BOOKS:

1. Guidebook for drug Regulatory submissions by Sandy Weinberg, Clayton state university, Copyright © 2009 by John Wiley & Sons, Inc. Published by John Wiley & Sons, Inc., Hoboken, New Jersey
2. Real World Drug Discovery, A Chemist’s Guide to Biotech and Pharmaceutical Research by Robert M. Rydzewski Copyright _ 2008 Elsevier Ltd Elsevier The Boulevard, Langford Lane, Kidlington, Oxford OX5 1GB, UK, Radarweg 29, PO Box 211, 1000 AE Amsterdam, The Netherlands
3. Reliable design of medical devices / Richard C. Fries.–2nd edn. Published in 2006 by CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742

REFERENCES:

1. New Drug Approval Process, R.A.Guarino,4th Edition , Marcel Dekker, NY
2. New Drug Approval Process Global Challenges and Solutions RICHARD A. GUARINO., Fifth Ed. informa Healthcare
3. DRUGS From Discovery to Approval, Second Edition RICK NG, A-Bio Pharma Pte Ltd, Singapore, Copyright © 2009 Published by John Wiley & Sons, Inc., Hoboken, New Jersey
4. New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics, edited by Chandrahas G. Sahajwalla
5. Drug discovery from Bedside to Wall Street Tamas Bartfai & Graham V. Lees, 2006,ElsevierInc Elsevier Academic Press, 30 Corporate Drive, Suite 400, Burlington, MA01803, USA
6. Drug discovery and development / edited by Mukund S. Chorghade Copyright © 2007 by John Wiley & Sons, Published by John Wiley & Sons, Inc., Hoboken, New Jersey.
7. FDA administration enforcement manual/ Florence R. Parker, © 2005 by CRC Press LLC, CRC Press LLC, 2000 N.W. Corporate Blvd., Boca Raton, Florida 33431.( Taylor & Francis Group, the academic division of T&F Informa plc.)
8. Commercial Manual onDrugs and Cosmetics 2004, 2nd edition Published by Commercial Law Publishers (India) Pvt. Ltd., Dehli.
9. Good Manufacturing Practices for Pharmaceuticals, S.H. Wiling, Vol. 78, Marcel Decker.
10. Protection of Industrial Property rights by P.Das and Gokul Das
11. Webistes: fda.org, wipo.int, patentlawlinks.com, hc-sc.gc.ca, ich.org
12. Marketing authorization of pharmaceutical Products with special reference to Multisource (generic) products: A manual for drug regulatory authorities WHO Division of Drug Management and Policies in Geneva from 7 to 8 April and 6 to 8 July 1998

For all other M.Pharm 1st Year 2nd Sem syllabus go to JNTUH M.Pharm  Quality Assurance and Pharma Regulatory Affairs  1st Year 2nd Sem Course Structure for (R17) Batch.

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