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Overview of the New EU Clinical Trial Regulation

Basel,

October 27 @ 9:00 am - 5:00 pm CEST

 

 

This course is ideal for anyone requiring an overview of the EU Clinical Trial Regulation and changes for EU trials. It will provide essential understanding to help with compliance with the new Regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.

 

COURSE OVERVIEW

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC).  Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submitting clinical trial information through a single point of entry. The go-live of the centralised clinical trial portal is scheduled for December 2021.

COURSE OBJECTIVES

• Gain a comprehensive overview of the EU Clinical Trial Regulation and changes for trials in the EU
• Review how the new regulation differs from the previous directive
• Discuss the implementation of the Clinical Trial Regulation Delegated Acts and other implementation documents
• Understand the new clinical trial authorisation process for regulatory approval and ethical approval

KEY TOPICS

• Background to the EU Clinical Research Regulation (Eu. No 536/2014)
• Understand the framework of clinical trial regulations in Europe
• Changes in the new EU Clinical Trial Regulation
• Overview of the major new requirements of the clinical trial regulation including: TMF, Risk-based evaluations, Non-EU sponsors, Transparency, Informed consent, Trials in emergency situations, Serious breaches in GCP, Pharmacovigilance and adverse event reporting, and Investigational medicinal product
• The new centralised portal for clinical trial regulatory and ethical authorisation

WHO SHOULD ATTEND?

Anyone requiring an understanding and update on the new EU Clinical Trial Regulation 536/2014. It is relevant for those working in clinical researchclinical operationsclinical project managementregulatory affairspharmacovigilancequality assurance (GCP auditors), vendor/CRO professionals, study sites and other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products.

It will also be of interest to those departments who liaise/support clinical trial personnel, and all other professionals who want to know more about the EU Clinical Trial Regulation

COURSE LEADER

Dr Laura Brown is an independent QA and training consultant and Director of the MSc in Regulatory Affairs, TOPRA and Senior Lecturer, MSc Clinical Research, School of Pharmacy, University of Cardiff. Laura has many years’ experience in the pharmaceutical industry, having worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She has worked as a Director of Clinical Research, audit director and head of a training department. Laura is an international expert on regulatory requirements.  She is author of several articles on the new EU Clinical Trial Regulation and has written a chapter on GCP in International Pharmaceutical Product Registration.

LEARNING METHODOLOGY

Interactive sessions with a mix of lecture, group exercises and discussions.

CONTINUING EDUCATION

This course is accredited by the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM).

FEE

Registration Fee: CHF 850.00 + 7.7% VAT
15 % reduction for members of SwAPP and SBA
Special fees for CTC employees
Group discounts available, please contact training@ctcresourcing.com

The fee includes course documentation, refreshments, lunch and a course participation certificate.
Payment: After registration you will receive confirmation and an invoice with instructions on how to complete the bank transfer.
Full prepayment is needed prior to the course.

CANCELLATION POLICY

• Cancellations received more than 14 days before course: 100% refund less bank charges & cancellation fee of CHF 50.00
• Cancellations received 7-14 days before the course: 50% refund
• Cancellations received 7 days before the course: no refund
• In case of no show, no refund will be made.

COURSE FLYER

New EU CTR_pgm flyer.pdf

Online Registration Form

If you have NOT received an official confirmation 7 days after registering, please call CTC at 0041 61 695 88 66 or send an email to training@ctcresourcing.com.

THANK YOU!

Details

Date:
October 27
Time:
9:00 am - 5:00 pm CEST

Venue

CTC Office
Münchensteinerstrasse 41
Basel, Basel-Stadt 4052 Switzerland
+ Google Map
Phone:
+41 61 695 88 66
Website:
www.ctcresourcing.com

Organiser

CTC Office
Phone:
+41 61 695 88 66
Email:
training@ctcresourcing.com
Website:
www.ctcresourcing.com