PhD THESIS TOPICS AND MATERIALS IN PHARMACY
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PhD THESIS TOPICS AND MATERIALS IN PHARMACY
1 Similarities and Difference between US DMF, Canadian DMF and eDMF
2 Similarities and Differences in Approval procedure for New Drug Application in Nigeria
3 Comparative study of New Drug Application Procedure in Nigeria
4 Recent Advances in Regulations for Labeling and Advertising in Nigeria
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 Nigeria Drug Regulatory System v/s Ghana Drug Regulatory Systems
38 Challenges in designing ANDA for Parenteral Products
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)
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)
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