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Overview of the New EU Clinical Trial Regulation
October 27, 2021 @ 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.
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 now scheduled for end of January 2022.
• 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
• 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 research, clinical operations, clinical project management, regulatory affairs, pharmacovigilance, quality 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
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.
Interactive sessions with a mix of lecture, group exercises and discussions.
The training will be delivered via digital platform. In order to get access you will need an internet connection, audio (from computer speakers or microphone), and a webcam (standalone or integrated with your monitor/laptop).
This course is accredited by the Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM).
Registration Fee: CHF 680.00 + 7.7% VAT
15 % reduction for members of SwAPP and SBA
Special fees for CTC employees
Group discounts available, please contact email@example.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.
• 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.
Virtual Classroom: 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 firstname.lastname@example.org.