E-learning: Overview of the Clinical Trials Regulation 536/2014: what will change in the EU?

The Clinical Trials Regulation 536/2014 (or CTR) enters in force on January 31, 2022 and will replace the existing Directive 2001/20/EC at the end of the transition period, on January 31, 2025. This new regulation will improve the collaboration and the efficiency of the processes related to clinical trials applications and will impact everyone involved in clinical trials conducted within the European Union.
We created this online course to help you get up to speed on the key aspects of this major change of the European clinical research landscape.

Our experts, involved in the development of the CTR since its inception, have analysed the law and extracted for you the essential points to take into account. In addition, this course raises awareness on most impactful changes to foresee within sponsor organizations and contains recommendations on actions to implement for a successful transition to the CTR.

Additional information

Targeted audience

Clinical research professionals involved in the conduct of clinical trials in EU: Pharma sponsors, CROs, academic sponsors, hospital clinical research units. from operational to management levels whether the organization is located in the EU or not.

Objectives

The objectives of this e-learning are twofold:
• Understand the main components of the new EU regulation 536/2014 on clinical trials (main changes brought, implementation timeline, evaluation process, clinical data transparency and safety aspects, etc…).
• Understand the changes in the current practice that will need to be put in place and understand some of the main challenges that sponsor organizations will face.

Duration of the of the course

75 minutes

Language

English

Certification

A certificate of completion will be delivered at the end of the training.

290.00

Competencies acquired at the end of the training

You will acquire an understanding of:

  • The fundamental principles of the CTR 536/2014.
  • The content of the clinical trials application dossier.
  • The timeline for implementation of the regulation until the currently applicable directive is repealed.
  • The coordinated evaluation processes for Part I and Part II.
  • The elements that will remain within the area of responsibility of the member states.
  • The role of the CTIS (Clinical Trials Information System).
  • The new transparency mechanisms for public access to the clinical trials information.
  • The changes in safety assessment.
  • The clinical trials regulation challenges for the sponsors and how to tackle them.

Content of the course

10 chapters, 7 of them containing quizzes to reinforce acquisition of the key take-home messages:
1. Regulatory background
2. Implementation of the regulation
3. Transition from the Directive to Regulation 536/2014
4. Key differences introduced by the regulation
5. Overview of submission and authorization processes
6. Technical aspects of the CTR, and Transparency
7. Safety reporting and assessment
8. Key challenges of the CTR
9. What needs to be done to implement the CTR?
10. CTR implementation support.

Why doing this training with us?

ObelysQ and Intagest are directly involved with their clients in the implementation of the clinical trials regulation 536/2014 and related compliance aspects. We are much more than a training company; we have decades of experience in clinical trials and what we share is based on field experience, going through pain points and opportunities for improvements that every new legislation brings.

Authors of the training:

Intagest (Spain):
Fabien Peuvrelle

Fabien Peuvrelle, holder of a Pharm.D and of a Law degree in Regulatory Affairs, Fabien boasts 25 years of regulatory affairs experience in the pharmaceutical industry, including leading the clinical trials applications group, in companies like Novartis and Celgene. He is a Senior Consultant at Intagest since 2018. Involved as subject matter expert for the Pharmaceutical Industry during the Clinical Trials Regulation discussions in the EU Parliament, and later in the early stages of the development of the CTIS, he has been keeping a close eye on the developments that led to the coming into force of the clinical trials regulation on Jan 31st, 2022.

ObelysQ SA (Switzerland): Arnaud Levain Chavanon

Arnaud is Pharm D. and holds a Master's Degree in Quality Assurance. He has lived in several countries (France, United Kingdom, Belgium, and Switzerland) and has been in the GCP environment for over 20 years working for major pharma companies such as Novartis, Bayer, Wyeth, UCB and Celgene. Arnaud has conducted 200+ audits, has managed dozens of Health Authority inspections and has been a leader in enhancing clinical processes in various organizations. In 2016, Arnaud decided to leave Celgene where he was Clinical Quality Assurance Director in the Clinical Quality Assurance department to become a consultant. He has since completed a variety of projects such as gap analyses, GCP audit programs, GCP training sessions, SOP development, and GCP consultancy, for multiple customers around the globe.

ObelysQ SA (Switzerland): Ludovic Moulin

Ludovic has a B.Sc in Microbiology and Immunology, a DESS in Management, and a M.A in International Relations. He has worked in the field of Quality Assurance for over 15 years. First starting in the GMP/GLP area in a Pharmaceutical Microbiology lab, he then moved to GCP to broaden his knowledge quality assurance principles. After working for five years in Canada, he relocated to Switzerland to join the Clinical Quality Assurance department of Celgene where he became an Associate Director and Program Lead. Throughout the years, Ludovic has supported many Health Authority inspections across the globe and was entrusted to perform audits in America, Europe, and Asia. Amongst his peers, Ludovic is appreciated for his leadership, interpersonal skills, communication skills, and business acumen.

How can we support you?

Finding one’s way in this totally new clinical trials regulatory landscape represents a noticeable effort that may require external help. For that aim, Obelysq and Intagest have joined forces and developped a full range of services to support their clients in an efficient implementation of the clinical trials regulation. Whether you are a biotech, a small to large pharma, an Academic Sponsor or a CRO, whether you are based in the EU, in Asia-Pacific or in Americas, our experts will be at your side all along. 

 

Choose from our best-in-class services in order to:

  • Raise internal awareness of the changes, with live, remote or on-site, tailored training classes
  • Plan implementation, through in-depth evaluation of your processes, SOP landscape and clinical trials portfolio.
  • Deliver implementation of new processes, including support on the initial EMA Clinical Trial Information System submissions.
  • Ensure long term compliance. by contracting us for long term support, to handle your clinical trials submissions, conduct regulatory intelligence and run effectiveness checks.

After getting up to speed on the clinical trials regulation with our online training you will be able to better seize the kind of effort that will be required for your business. Then, just get in touch and lets discuss your needs.

Obelysq and Intagest: your partners for your implementation of the clinical trials regulation.