Course

Unit 1

a. Documentation in Pharmaceutical industry:(20 hrs)

Master formula record, DMF (Drug Master File), distribution records (3 hrs)

Investigation of medicinal products dossier, dossier (IMPD) and investigator brochure (IB).(2 hrs)

Generic drugs product development Introduction, Hatch- Waxman act and amendments,(2 hrs)

CFR (CODE OF FEDERAL REGULATION), drug product

performance, in-vitro,(2 hrs)

Documents related to IND, ANDA regulatory approval process, NDA approval process,(3 hrs)

BE and drug product assessment, in –vivo, scale up process approval changes,(2 hrs)

post marketing surveillance, outsourcing BA and BE to CRO.(2 hrs)

b. Regulatory requirement for product approval (4 hrs): API, biologics, novel, therapies obtaining NDA, ANDA for generic

drugs ways and means of US registration for foreign drugs

Unit 2

CMC, post approval regulatory affairs:(12 hrs)

Regulation for combination products and medical devices. CTD and ECTD format, industry and FDA liaison.

ICH – Guidelines of ICH-Q, S, E and M. Regulatory requirements of EU, MHRA, TGA and ROW countries.

Unit 3

Non-clinical drug developments: (7 hrs)

Regulatory aspects of product development in GMP,

DCGI pre-clinical requirements for approval of clinical trials: Animal pharmacology: Specific pharmacological actions, General pharmacological actions,

Follow-up and Supplemental Safety Pharmacology Studies Pharmacokinetics: absorption, distribution; metabolism; excretion

Animal toxicology studies: Systemic Toxicity Studies, (i) Single dose toxicity studies (ii) Dose Ranging Studies (iii) Repeat-dose systemic toxicity studies.

Global submission of IND, NDA & ANDA.

Unit 4

Clinical trials: (6hrs)

Developing clinical trial protocols.

Institutional review board/ independent ethics committee Formulation and working procedures informed Consent process and procedures.

HIPAA- new, requirement to clinical study process,

pharmacovigilance safety monitoring in clinical trials.

This course is designed to impart advanced knowledge on the journey of new drugs from bench to bedside. This course describes the way of different pharmaceutical records maintenance; signifies the in vitro-in vivo correlation, bioequivalence studies and their role in pharmaceutical regulatory approval scale up process. This course describes different clauses and regulatory requirements for generic drug development. This course also describes the way for formation of common technical documentations, and guidelines for combination products. This course also highlights the guidelines for International Council of Harmonization and pharmaceutical regulatory requirements of different countries. This course imparts throw knowledge in animal pharmacology and animal toxicology study for DCGI requirements for approval to conduct clinical trials.

Through this course, students develop skills in documentation preparation for pharmaceutical industries and various regulatory agencies. This course exposes students to the development of clinical trial protocols and different phases of clinical trials. Students understand the system for drug safety monitoring during clinical trials. Students also learn fundamentals of drug safety monitoring and health insurance portability process. The overall goal is to develop the students’ understanding and skills so that they can become future regulatory affairs professionals. Students are prepared to play an important role in ensuring the safety and efficacy of pharmaceutical products, as well as compliance with regulatory authorities’ regulations and guidelines.

Upon successful completion of the course, the student shall be able to

KNOWLEDGE

K1: Discuss the approval process of innovator and generic drugs K2: Describe Regulatory guidelines for filing and approval process K3: Compare regulatory requirements of different countries

K4: Elaborate the requirements for approvals for conducting clinical trials K5: Design safety monitoring system in clinical trials.

K6: Explore post approval regulatory requirements for actives and drug products

SKILL

S1: Prepare dossiers for submission to regulatory agencies in different countries S2: Identify the ethical issues of clinical trials.

S3. Assess the responsibilities of Institutional Review Board. S4: Investigate the conditions sufficient for ANDA.

S5: Measure the cost of drug development S6: Develop the clinical trial protocol.

ATTITUDE:

A1. Appreciate the work of others.

A2. Demonstrate sincerity and punctuality.

A3. Build the role model skill.

A 4. Participate actively in the discussion during class.

A 5. Support your team members for better outcomes.

A 6. Demonstrate interest, motivation, and self-evaluation for learning beyond classroom

1. Leon Shargel and Isader, Generic Drug Product Development, Solid Oral Dosage forms, Kaufer,Marcel Dekker series, Vol.143, 2005.
2. Guarino R A, New Drug Approval Process: Accelerating Global Registrations, 5th edition, Drugs and the Pharmaceutical Sciences,Vol.190, 2009.
3. Pisano D J, Mantus FDA regulatory affairs: a guide for prescription drugs, medical devices, and Biologics, by CRC Press. 2008.
4. Rozovsky F A and Adams R Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance, 2003.
5. Berry R I and Martin R P, The Pharmaceutical Regulatory Process, 2^nd Edition, Vol.185,Informa Health care Publishers. 201.
6. Weinberg Guidebook for drug regulatory submissions, By John Wiley & Sons.Inc. 2009.

Website

1. ich.org/
2. fda.gov/
3. eu/index_en.htm
4. https://www.tga.gov.au/tga-basics

ASSIGNMENTS

1. Describe Hatch- Waxman act and its
2. Group task: discuss different terms and conditions for ANDA
3. Report on Industry and FDA liaison with
4. Group task: Prepare a comparative report on regulatory requirements of EU, MHRA, TGA and ROW countries
5. Prepare an investigator brochure
6. Group task: Study a pharmacovigilance safety monitoring

Journals:

International Journal of Pharmaceutics (Elsevier) BMC Health Services Research (BMC)

Drug Discovery Today (Elsevier)

Therapeutic Innovation and Regulatory Science (Springer Nature)