Module 5 Presentations

Module 5: Regulatory Control of Clinical Operations 17 th – 19 th July 2024 Date: Thursday 18 th July 2024

Time

Activity

Speaker

08.30 – 08.45

Introduction

Chairperson: Eva Kopecna Acino International

08.45 – 09.30

Lecture 4: Pharmacovigilance & adverse event reporting in clinical trials Adverse Event Reporting - -General requirements and definitions Safety reporting in the EU Pharmacovigilance. Future Proposals Lecture 5: Regulatory requirements for clinical trials - EU Requirement for and Format of Medical Device Clinical Trials Regulatory Requirements under EU-MDR and MDCG guidance. Role of Standards in Device Clinical Trials Particular considerations for UK-NHS and EU sites. Lecture 5: Regulatory requirements for clinical trials – EU Cont’d Current Legislation Requirements The Clinical Trial Regulation and its Impact CTA applications / Medical Devices Ethics Committee Submissions Reporting of clinical trials. Industry experience Lecture 6: Regulatory requirements for clinical trials of medical devices Refreshment Break

Beatrice Panico Scendea

09.30 – 10.30

Neil R Armstong MeddiQuest Europe, North America and UK

Mariona Casals Cases

10.30 – 11.00

11.00 – 12.00

Pierre Omnes Transperfect Life Sciences

12.00 – 13.00

Deepa Subramaniyan Roche (remote)

13.00 – 14.00

Lunch

14.00 – 14.45

Lecture 7: The successful IMPD Contents of the IMPD Pitfalls Updates

Graham Bell Icon

14.45 – 15.30

Lecture 8: GMP, authorisation and importation requirements, clinical trial

Pierre Omnes Transperfect Life Sciences

supplies management 2003/94/EC GMP Directive

15.30 – 16.00

Refreshment Break

16.00 – 16.05

Introduction to Case Study 1

Pierre Omnes Transperfect Life Sciences

16.05 – 17.00

Manufacturing and importation requirements including the role of the QP Regulatory framework under which clinical supplies are managed Planning of a clinical supplies programme Issues relating to manufacture, packaging and distribution of clinical supplies Case Study 1: Initiation of a Clinical Trial Feedback from Case Study 1

17.00 – 17.30