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PhD THESIS TOPICS AND MATERIALS IN PHARMACY

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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