Programme

Title: Face-to-face meeting: EMA regulatory process for clinical trials
Trainer: Laura Brown
Duration: 1 day
Date and time: 1 March 2019; 09:00–16:30
Location: Amsterdam, Netherlands
CME accreditation: Pending

09:00–09:20

 

Welcome and introductions

All

09:20–10:00
40 minutes

S1: Key regulatory and guidelines requirements
for setting up and running clinical trials

  • EU Clinical Trial Regulation (536/2014) for clinical trial authorization
  • Ethical approval
  • 35-minute lecture
  • 5-minute moderated discussion

10:00–11:00
60 minutes

S2: The importance of ICH GCP R2 guideline requirements
for running clinical trials

  • International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) principles
  • Investigator responsibilities and discussion on how to demonstrate these
  • Informed consent considerations (discussion of the essential requirements to include)
  • Trial documentation
  • Ensuring quality and data integrity
  • 45-minute lecture
  • 15-minute moderated discussion

 

11:00–11:20 

Refreshment break and interactive poster wall

All

11:20–12:15
55 minutes

S3-a Practical exercise: Setting up a clinical trial
(for new drugs and for existing drugs in a new indication)

  • Obtaining permission to start a clinical trial
  • Submission to an ethics committee 
  • Discussion of country-specific differences
  • Interactive sharing of experiences

Workshop/working in smaller groups

 

12:15–13.00

Lunch

All

13:00–14:00
60 minutes

S3-b Practical exercise: setting up a clinical trial (continued)
(for new drugs and for existing drugs in a new indication)

  • Obtaining permission to start a clinical trial
  • Submission to an ethics committee 
  • Discussion of country-specific differences
  • Interactive sharing of experiences

Workshop/working in smaller groups

 

14:00–14:30
30 minutes

S4 Managing investigational medicinal products

  • Labelling
  • Storage
  • The role of the Qualified Person (QP)
  • 25-minute lecture
  • 5-minute moderated discussion

 

14:30–15:15
45 minutes

S5 Pharmacovigilance requirements

  • Pharmacovigilance and adverse-event reporting
  • Safety reporting definitions and requirements
  • Reporting requirements for suspected unexpected serious adverse reactions (SUSARs), adverse events, and adverse reactions

Including refreshments in the room

  • 30-minute lecture
  • 15 minutes working in groups

 

15:15–15:45
30 minutes

S6: Legal aspects of clinical trials

  • Insurance
  • Liability
  • Contracts
  • Study site findings
  • 20-minute lecture
  • 10 minutes working in groups

15:45–16:30
45 minutes

S7: Latest developments: GDPR (May 2018)
in the context of clinical trials

  • Overview of General Data Protection Regulation (GDPR) key requirements
  • Transparency and patient information
  • Data breaches  
  • 35-minute lecture
  • 10 minutes working in groups

 

16:30

Summary and close

All

This training programme is made possible by a contribution from Novartis Pharma AG. Novartis does not have any influence on the content and all items are subject to independent peer and editorial review.

This programme is organized by Ology, a global provider of independent medical education that develops CME initiatives for the international medical and scientific community. Ology is an Adelphi in Healthcare Communications company. For further information about other Adelphi companies please see the Adelphi Group website.

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