Continuous Education by Perfect Pharmaceutical Consultants Pvt.

Ltd, Pune, India

100 HOT TOPICS FOR DISSERTATION FOR PG

DIPLOMA/ DEGREE IN REGULATORY AFFAIRS

Mr. R.M. Gupta (M. Pharm.), is a free lancer consultant for US DMF, COS,
ANDA, ACTD, CTD, eCTD and he is also the director of Global Institute of
Regulatory Affairs, Pune. He is also associated with Perfect Pharmaceutical
Consultants Pvt. Limited (Pune, India) an organization providing regulatory
solutions to Drug Industry for the last 25 years.

Abstract: The Post Graduate education courses in RA generally require submission

of a dissertation on some current topics in drug regulations. The quality of the
dissertation indicates the knowledge and understanding of the subject matter.

This article is specially written to guide RA students for selecting the most current
regulatory topic and to design a powerful dissertation on the same.

The students are s are invited to post their queries at guptarmg1952@gmail.com

INTRODUCTION

Post Graduate Training and Diploma in Regulatory Affairs is rising rapidly in India
and abroad. Currently there are more than 100 Schools all over the world which
imparts Post Graduate Diploma, M.Sc. or M. Pharma in RA. One of the major criteria
for qualification RA is dissertation/course work/project profile of 10,000 to 15,000
words on a topic provided by the Course Director.

A good dissertation shall demonstrate that the student has understood the topic from
all regulatory angles. It shall be supported by references to the peer reviewed articles
from literature. It may also include References to the regulatory experts who were
consulted by the student to understand the practical aspects of the subject matter.

The dissertation must be the original work of a single student.

The topic for dissertation shall be of current importance to impact the examiner
The students are advised to present the dissertation must in a clear and professional
manner.

Once the submission is ready it shall be self checked by the student for the following
points

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Continuous Education by Perfect Pharmaceutical Consultants Pvt. Ltd, Pune, India

CHECKLIST FOR REGULATORY DISSERTATIONS

1 If the cover pages presents the title of the presentation, version number and
name of author and the date of final editing and the date of submission.
2 If the subsequent page presents the purpose of dissertation and
acknowledgements to the contributors
3 If the detailed index is provided for the presentation
4 If all the sections and sub-sections are clearly written with ample white space?
5 Does the page layout, spacing, tabular presentation, graphical presentations
look professional rather than like a simple typing job?
6 Does the presentation is visually pleasant?
7 If the presentation has polished appearance
8 If the generally acceptable fonts fonts such as such Times New Roman is
used through out?
9 Are the design elements such as Tables, Graphs, font size, Font types, Bolding
are used appropriately for easy reading and quick capturing by the eyes?
10 If there is good balance between text and white space?
11 Are margins even on all sides?
12 Are design elements like spacing and font size used consistently throughout
the document?
13 If all the pages are properly numbered and captioned and the page breaks are
formatted properly?
14 Are all sections clearly captioned?
15 Are sections placed in perfect order as detailed in CTD Guidelines?
16 If the submission is specific to the scope as defined by the course director?
17 Does the data indicate the appropriate compliance with current drug
regulations?
18 Do the submission uses scientific and regulatory terminology?
19 Does the submission meet all regulatory guidelines and specifications?
20 If the content flow is logical and easy to understand?
21 If the dossier is as perfect as possible, with no careless technical, typo,
spelling, grammar and syntax errors?
22 If the bibliography is presented in most scientific manner
23 Does the presentation includes authors own statements
24 Does the presentation provide suitable references for the text taken from
standard books, journals and regulatory guidelines?

TOPIC FOR DISSERTATION WORK

It must be current, novel, creative and meaningful .Ideally it shall add value to the
Regulatory Compliance. The selected topics may provide critical review and solutions
to regulatory submissions. The followings are top most 100 topics for regulatory
research and dissertation work.

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Continuous Education by Perfect Pharmaceutical Consultants Pvt. Ltd, Pune, India

100 TOPICS FOR REGULATORY RESEARCH AND

DISSERTATION WORK

1 Similarities and Difference between US DMF, Canadian DMF and eDMF

2 Similarities and Differences in Approval procedure for New Drug
Application in USA and EU
3 Comparative study of New Drug Application Procedure in US,EU and India
4 Recent Advances in Regulations for Labeling and Advertising in USA
5 Common Deficiencies in Regulatory submissions
6 FDA Review Procedures for NDA,ANDA and DMF
7 EDQM Review Process for CEP
8 Role of Post Approval Clinical Trials for Drug safety
9 Resources for scientific and technical information for designing Regulatory
Submissions
10 Current Deficiencies in Schedule Y
11 Current Role of GMP Audit for Marketing Authorizations of API
12 Current Regulations for Marketing Authorization of Pharmaceutical
Excipients
13 Current Regulations for Marketing Authorization of Pharmaceutical
Packaging Materials
14 Marketing Authorization of New Drug substance in USA
15 Marketing Authorization of New Drug substance in Europe
16 Regulatory Guidelines for Product Development
17 Critical and Comparative Analysis of Marketing Authorization Procedures in
Developing Countries
18 The Role of RA in Pharmaceutical Exports
19 Risks and Opportunities in Development of New Drug
20 Question based Review of Regulatory Compliance
21 Electronic Regulatory Submissions
22 Principles and Guidelines for Regulatory Affair of Pharmaceutical Products
23 Conflicts and Solution Trends in Regulatory issues
24 Challenges and Prospects for filing CEP in Europe
25 Standard Practices in Regulatory Compliance
26 FDA 483 Notifications
27 Challenges in Regulatory Filings for Generic Products
28 Current Regulations for Herbal Products
29 Current Regulations for Biological Products
30 Role of ICH in Harmonizing Drug Regulations
31 Regulatory System in ICH Region
32 Regulatory System in ASEA
33 Regulatory System India
34 Latest Regulations for BE studies for the approval of ANDA
35 Current trends in Regulatory Actions against Misbranding and Adulteration
36 Design and development of National Drug Regulatory System and Policies
37 US Drug Regulatory System v/s European Drug Regulatory Systems
38 Challenges in designing ANDA for Parenteral Products

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Continuous Education by Perfect Pharmaceutical Consultants Pvt. Ltd, Pune, India

39 Challenges in designing CEP on Anticancer Products

40 Challenges in drafting CTD Module 2 (Clinical and Nonclinical Summary)
41 Strategy for Regulating Regulatory Functions
42 Role of Regulatory Affairs in Marketing Pharmaceutical products
43 Regulatory strategy for filing NDA/ ANDA
44 Regulatory strategies for successful pan-European registration
45 Strategic Planning for Regulatory submissions
46 The effective strategies for interactions with Regulatory Agencies
47 The commercial aspects of regulatory approvals
48 Electronic Common Technical Document submissions
49 Interrelationship between Regulatory Affairs, Quality Control and Quality
Assurance for regulatory submissions
50 Regulatory issues for import of Pharmaceutical Products into India
51 Regulatory issues for export of Pharmaceuticals products to Latin America
52 Regulatory issues for export of Pharmaceuticals products to countries under
ROW
53 Malpractices in Regulatory Submissions (MRS)
54 ICH Guidelines for Impurity Profiling
55 Role of Training in Regulatory Compliances
56 Principle of Regulatory Compliance (PRC)
57 Market authorizations in Latin America
58 Life Cycle of Drug Regulations (LCDR)
59 Latest Trends in Regulatory Compliance Training
60 Current Trend in Liaison with Regulatory Authorities
61 Current Trends in Regulatory Projects Management
62 Regulatory Aspects of Contracts Manufacturing
63 Pharmacopeial Standards for API
64 Current Trends in Review of CTD Dossiers
65 CEP Project Management
66 Mutual Recognization Procedures (MRP)
67 MAA Project Management
68 Product Registration Strategies
69 Current Appraisal Procedures for New Regulations, Standards, Policies, and
Guidance issued by Regulatory Authorities
70 Current Trends in Planning, Preparation and Delivering Regulatory
Submissions
71 Current Regulations for Variation Filings for the registered products
72 Good Practices in Evaluation and solutions to the deficiencies in CTD
Submissions
73 Good Practices in updating Regulatory Filings.
74 Current Trend in follow-up procedures with MOH for the registration of
Pharmaceutical products
75 Current Regulations for labeling and Advertising of Medicinal products
76 Good Practices for the Management of Quality Audits conducted by
Regulatory Authorities
77 Good Practices in Management of comments/deficiencies in CTD/ACTD
78 Knowledge Management in RA (KMRA)
79 International Regulatory Framework (IRF)

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Continuous Education by Perfect Pharmaceutical Consultants Pvt. Ltd, Pune, India

80 Review and Approval Procedures for Promotional Materials

81 Regulatory Practices in CIS Countries
82 Current Regulations for Clinical Trials
83 Role of COPP in Pharmaceutical exports
84 Risk Analysis of Regulatory Non Compliance
85 Current Compendia Standards for Drug Products
86 Current Compendia Standards for API
87 Review of Responsibilities and Expectations from RA Professionals
88 Self Audit procedures for Regulatory Compliance Issues
89 Latest trends in Archiving of Regulatory Submissions
90 Corrective and Preventive procedures for Regulatory Compliance
91 Review of Regulatory Guidelines available on Web
92 Review of Free Regulatory Knowledge Resources on Web
93 Current Practices in Solving Complex Regulatory matters
94 Trends in the Management of Relations with Health authorities
95 Role of QMS (Quality Management System) for effective Regulatory
Compliance
96 Master Regulatory Compliance Program (MRCP)
97 Recent Developments in Regulatory Compliance Strategies,
98 FDA Litigation Procedures for Regulatory Noncompliance
99 Annual Regulatory Compliance/Noncompliance Review Procedures
100 Trends in designing chemistry, manufacturing and controls (CMC)
components of regulatory submissions
101 Recent trends in Training Regulatory Project Team Members, Cross
functional teams, Senior management and Regulatory consultants associated
with the company.
102 Patent issues in ANDA Approval
103 Good Practices in Organizing Regulatory Compliance Projects
104 Management of NC Reports /Queries issued by MOH
105 Review of the Current Status of Schedule Y
106 Good Regulatory Compliance Practices (GRCP)

ASSESSMENT OF DISSERTATION AT GIRA

The overall aim of the dissertation is to train the student for deep understanding of the
regulations to resolve complex regulatory problems most economically, rapidly and to
the full satisfaction of the regulatory authorities Assessment of dissertation is a
complex affair. At GIRA all dissertation are critically checked for presentation and
basic understanding of the project by a Primary Regulatory Expert and by Course
Director. Please refer the Annexure for the format used by GIRA for dissertation
assessment.

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Continuous Education by Perfect Pharmaceutical Consultants Pvt. Ltd, Pune, India

CONCLUSION

Dissertation writing is a critical element for Graduate/Post Graduate Course in RA.

Dissertation is an evaluation of Intelligent Quotient and Regulatory Knowledge of RA
students. The topic for the dissertations shall be of current importance and the
presentation must display deep understanding of the relevant regulations.

Note: For any help on dissertation design, writing and evaluation please contact the
author

Rajkumar M. Gupta

Managing Director- Perfect Pharmaceutical Consultants Pvt .Ltd

Director-Global Institute of Regulatory Affairs (GIRA)
Drug Regulatory Affairs Consultant and Regulatory Affairs Trainer
(CTD, eCTD, DMF,CEP, ANDA Designer and Reviewer)

Regd. Office: - Prestige Classic (D Wing)

Dawa Bazar, Pune Mumbai Express Highway,
Chinchwad, Pune 411019, Maharashtra, India.

Contact Mobile No.:- +91-9371020504

E-Mail:- guptarmg1952@gmail.com
Web: www.regulatoryinstitute.com
Article Links - https://sites.google.com/site/ppcdmf/announcements

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Continuous Education by Perfect Pharmaceutical Consultants Pvt. Ltd, Pune, India

APPENDIX

DISSERTATION EVALUATION FORM AT GIRA

(Subject: )

No. Parameter Marks Primary Secondary

Allotted Evaluation Evaluation
1. Presentation 15
- Proper Index/ Numbering/ 5
Printing Layout
- Use of Diagrams/ 5
Flow charts
- Grammatical Errors 5
2. Content 20
- Technical content covered 10
- Depth of information 5
- Correctness/ Relevancy of 5
the information
3. Referencing 10
- Proper referencing 5
- Use of own language 5
4. Creativity/ Overall Conclusion 5
Total 50

Result (Average): /50 ( grade)

A Grade > 40 /50

B Grades 30 40 /50
C Grade 20 30 /50

Date and Sign and Comments by of Primary Evaluator

Date and Sign and Comments by Secondary Evaluator

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