Module 5 Presentations
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Front Cover
1
Agenda
2
Lecture 1: GCP - The platform for clinical research
5
Lecture 2: GCP Inspections – Agency Experience
46
Lecture 3: Progression of clinical trials in relation to the toxicology programme
66
Lecture 4: Pharmacovigilance & adverse event reporting in clinical trials
91
Lecture 5: Regulatory requirments for clinical trials Pt 1
102
Lecture 5: Regulatory requirements for clinical trials – EU Cont’d
114
Lecture 6: Regulatory requirements for clinical trials of medical devices
144
Lecture 7: The successful IMPD
155
Lecture 8: Lecture 8: GMP, authorisation and importation requirements, clinical trial supplies management
175
Lecture 9: Regulatory requirements for clinical trials - Japan
193
Lecture 10: Legal aspects of clinical trials
217
Lecture 11: Regulatory requirements for clinical trials – US and Canada
242
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