The document outlines the Master of Pharmacy program at Bengal College of Pharmaceutical Technology, focusing on the course in Regulatory Affairs. It details the course scope, learning objectives, outcomes, and a comprehensive lesson plan covering various regulatory processes and requirements in pharmaceutical development. The program aims to equip students with essential pharmacy knowledge, planning abilities, and professional skills relevant to the healthcare system.

1. Bengal College of Pharmaceutical Technology
Affiliated to Maulana Abul Kalam Azad University
Name of the Programme : Master of Pharmacy
Lesson Plan
Name of the faculty: Dr. Sudipta Roy Class: Master of Pharmacy 1st Semester
Name of the Course(Subject): Regulatory Affair Course Code: MPT1064
Scope of the Course (Subject):
This course has been developed to provide important knowledge and information, learning on
different technologies for method of regulatory affairs like the concept of generic drug and
their development, various regulatory filings in different countries, different phases of clinical
trials and submitting regulatory documents : filing process of IND, NDA and ANDA , to know the
approval process , to know the chemistry, manufacturing controls and their regulatory
importance , to learn the documentation requirements, to learn the importance.
Programme Outcome:
PO1: Pharmacy Knowledge-Possess knowledge and comprehension of the core and basic
knowledge associated with the profession of pharmacy, including biomedical sciences;
pharmaceutical sciences; behavioural, social, and administrative pharmacy sciences; and
manufacturing practices.
PO2: Planning Abilities- Demonstrate effective planning abilities including time management,
resource management, delegation skills and organizational skills. Develop and implementplans
and organize work to meet deadlines.
PO3: Problem analysis- Utilize the principles of scientific enquiry, thinking analytically, clearly
and critically, while solving problems and making decisions during daily practice. Find, analyze,
evaluate and apply information systematically and shall make defensible decisions.

2. PO4: Modern tool usage - Learn, select, and apply appropriate methods and procedures,
resources, and modern pharmacy-related computing tools with an understanding of the
limitations.
PO5: Leadership skills- Understand and consider the human reaction to change, motivation
issues, leadership and team-building when planning changes required for fulfillment of practice,
professional and societal responsibilities. Assume participatory roles as responsible citizens or
leadership roles when appropriate to facilitate improvement in health and wellbeing.
PO6: Professional Identity - Understand, analyze and communicate the value of their
professional roles in society (e.g. health care professionals, promoters of health, educators,
managers, employers, employees).
PO7: Pharmaceutical Ethics- Honour personal values and apply ethical principles in professional
and social contexts. Demonstrate behavior that recognizes cultural and personal variability in
values, communication and lifestyles. Use ethical frameworks; apply ethical principles while
making decisions and take responsibility for the outcomes associated with the decisions.
PO8: Communication-Communicate effectively with the pharmacy community and with society
at large, such as, being able to comprehend and write effective reports, make effective
presentations and documentation, and give and receive clear instructions.
PO9: The Pharmacist and society - Apply reasoning informed by the contextual knowledge to
assess societal, health, safety and legal issues and the consequent responsibilities relevant to
the professional pharmacy practice.
PO10: Environment and sustainability -Understand the impact of the professional pharmacy
solutions in societal and environmental contexts, and demonstrate the knowledge of, and need
for sustainable development.
PO11: Life-long learning- Recognize the need for, and have the preparation and ability to
engage in independent and life-long learning in the broadest context of technological change.
Selfassess and use feedback effectively from others to identify learning needs and to satisfy
these needs on an ongoing basis.
Course Outcome:
CO1: To acquire concepts of innovator and generic drugs, the process of drug development.
CO2: To explain regulatory guidance’s and guidelines for filing and approval process of
Investigational new drug (IND), New Drug Application (NDA), Abbreviated new drug application
(ANDA).

3. CO3: To Prepare Dossiers which contains the collection of detailed documents containing
information about a particular drug for submission to Regulatory Authority to get the grant of
Regulatory Approval in any country.
CO4: To describe Post approval regulatory requirements for actives and drug products.
CO5: To describe Post approval regulatory requirements for actives and drug products.
CO6: To describe the clinical trials requirements for approvals for conducting clinical trials and
Pharmacovigilance and monitoringprocess in clinical trial.
Programme Educational Objectives:
1. To furnish extensive and advanced knowledge of pharmaceutical education to conduct
quality pharmaceutical research.
2. To develop well educated pharmacy students for effective and sincere contribution to the
health care system in the society.
3. To implant the urge for entrepreneurship and leadership quality in the future professional
field.
Programme Specific Outcomes (PSOs):
PSO1: Acquire the basic knowledge and concepts of Pharmaceutical Science and Technology.
PSO2: Apply and expand the knowledge of all subjects in the research and development of
pharmaceutical formulations.
PSO3: Apply the knowledge of Pharmaceutical Science in predicting the drug information,
disease information, formulation development, safety and efficacy of medicines.
Number of Lectures:
Course Code Course Credit Hours Credit Points Hrs/wk Marks
MPT 1064 Regulatory 4 4 4 100

4. Affair
SL.No. Topics to be covered Tentative
date of
completion
Actual Date
of
Completion
Teaching/
Learning
Method
Signature of
Acadeamic
Coordinator
1 Documentation in
Pharmaceutical industry:
Master formula record, DMF
(Drug Master File).
16/07/2024
2 Distribution records. 19/07/2024
3 Generic drugs product
development Introduction
23/07/2024
4 Hatch-Waxman act and
amendments
24/07/2024
5 CFR (CODE OF FEDERAL
REGULATION)
26/07/2024
6 Drug product performance 30/07/2024
7 In- vitro approval process 31/07/2024
8 ANDA regulatory approval
process
2/08/2024
9 NDA approval process 6/08/2024
10 BE and drug product
assessment
7/08/2024
11 In –vivo, scale up process
approval changes
9/08/2024
12 Post marketing surveillance,
outsourcing BA and BE to
CRO.
13/08/2024
13 Regulatory requirement for
product approval:
14/08/2024

5. API obtaining NDA, ANDA
14 API obtaining NDA, ANDA 16/08/2024
15 Biologics obtaining NDA,
ANDA
20/08/2024
16 Novel obtaining NDA, ANDA 21/08/2024
17 Therapies obtaining NDA,
ANDA
23/08/2024
18 NDA, ANDA for generic drugs
ways
27/08/2024
19 US registration for foreign
drugs
28/08/2024
20 US registration for foreign
drugs
30/08/2024
21 Regulatory requirement for
product approval:
API obtaining NDA, ANDA
3/09/2024
22 Regulatory requirement for
product approval
4/09/2024
23 Regulatory requirement for
product approval
6/09/2024
24 Regulatory requirement for
product approval
10/09/2024
25 CMC 11/09/2024
26 Post approval regulatory
affairs
13/09/2024
27 Regulation for combination
products
17/09/2024
28 Medical devices 18/09/2024
29 CTD format 24/09/2024

6. 30 ECTD format 25/09/2024
31 Industry and FDA liaison 27/09/2024
32 Industry and FDA liaison 1/10/2024
33 ICH - Guidelines of ICH-Q, S E,
M.
4/10/2024
34 Regulatory requirements of
EU
8/10/2024
35 Regulatory Requirements of
MHRA
9/10/2024
36 Regulatory Requirements for
TGA and ROW countries
11/10/2024
37 Non clinical drug
development: Global
submission of IND
15/10/2024
38 Non clinical drug
development: Global
submission of IND
16/10/2024
39 Global submission of NDA 18/10/2024
40 Global submission of NDA 22/10/2024
41 Global submission of ANDA 23/10/2024
42 Global submission of ANDA 25/10/2024
43 Investigation of medicinal
products dossier
29/10/2024
44 Investigation of medicinal
products dossier
30/10/2024
45 Investigation of dossier
(IMPD)
5/11/2024
46 Investigation of dossier
(IMPD)
6/11/2024

7. 47 Investigator brochure (IB) 8/11/2024
48 Investigator brochure (IB) 12/11/2024
49 Clinical trials:
Developing clinical trial
protocols.
13/11/2024
50 Developing clinical trial
protocols
19/11/2024
51 Institutional review board/
independent ethics
committee Formulation and
working procedures
informed Consent process
and procedures
20/11/2024
52 Institutional review board/
independent ethics
committee Formulation and
working procedures
informed Consent process
and procedures
22/11/2024
53 Institutional review board/
independent ethics
committee Formulation and
working procedures
informed Consent process
and procedures.
26/11/2024
55 Institutional review board/
independent ethics
committee Formulation and
working procedures
informed Consent process
and procedures.
27/11/2024
56 HIPAA- new, requirement to
clinical study process.
29/11/2024
57 HIPAA- new, requirement to 3/12/2024

8. clinical study process
58 HIPAA- new, requirement to
clinical study process
4/12/2024
59 Pharmacovigilance safety
monitoring in clinical trials.
6/12/2024
60 Pharmacovigilance safety
monitoring in clinical trials.
10/12/2024
Name of the Programme: Master of Pharmacy Name of the Course: Regulatory Affair Subject Code:
MPT1064
Course Outcomes (CO) Objectives (Description)
CO1 To acquire concepts of innovator and generic drugs, the process of drug
development.

9. CO2 To explain regulatory guidance’s and guidelines for filing and approval process
of Investigational new drug (IND), New Drug Application (NDA), Abbreviated
new drug application (ANDA).
CO3 To Prepare Dossiers which contains the collection of detailed documents
containing information about a particular drug for submission to Regulatory
Authority to get the grant of Regulatory Approval in any country.
CO4 To describe Post approval regulatory requirements for actives and drug
products.
CO5 To describe Post approval regulatory requirements for actives and drug
products.
CO6 To describe the clinical trials requirements for approvals for conducting clinical
trials and Pharmacovigilance and monitoringprocess in clinical trial.
CO-PO matrics
CO'S Programme Outcomes (POs)
PO1
Pharmacy
Knowledge
PO2
Planning
Abilities
PO3
Problem
Analysis
PO4
Modern
Tool
Uses
PO5
Leadership
Skill
PO6
Professional
Identity
PO7
Pharmaceutical
Ethics
PO8
Com
muni
catio
n
PO9
Pharmacist
and Society
PO10
Environment
and
Sustsinability
PO11
Life
long
Learni
g
CO1 1 1 2 3 1 - - - 3 - 1
CO2 1 1 1 1 3 - - - 3 - 1
CO3 1 1 1 1 3 - - - 3 - 1
CO4 1 1 1 1 3 - - - 3 - 1
CO5 1 1 3 1 3 - - - 3 - 1
CO6 1 1 3 1 1 3 - 1 3 - 1