How EU 536/2014 Will Revolutionize Global Clinical Trials

How EU 536/2014 Will Revolutionize Global Clinical Trials

Webcasts

November 3rd 2022 9 am CT |10 am ET | 2 pm GMT | 3pm CET The way clinical trials are conducted in the European Union is undergoing major changes with (EU) No 536/2014. But just being compliant with the regulation should not be considered enough – forward-looking organizations are rethinking how technology can play an important part in bringing efficiencies to clinical trials, by reducing failures and driving operational changes beyond compliance.

Register Free: https://www.pharmexec.com/pe_w/revolutionize

Event Overview:

The new clinical trial regulation EU 536/2014 was enacted in 2014 with two clear objectives – make the EU more attractive for clinical trials and improve the quality of the study material submitted to EMA.


Time will tell if they are successful in attracting more clinical studies, but it is clear that if the quality of submissions does not improve it will have a measurable negative impact not just on European study timelines, but more importantly on global study timelines.


To streamline the European submission process, the regulation requires all EU countries to use the CTIS submission system, simplifying the process to get a clinical trial fully operational. To heavily incentivize high-quality submissions there are very severe (3, 6, 9… months) time penalties if a submission fails on the initial or subsequent submission. One current common occurrence that can cause such a delay is protocol amendments from submission to countries outside the EU.


This means that you must coordinate all global study submissions or the overall study timeline will incur these time penalties.


Key Learning Objectives:

  • What it requires to have the necessary oversight of the global submissions to avoid incurring global study time penalties.
  • What are the most critical global business roles to manage successful EU submissions.
  • What new system features are required to attain successful EU submissions.
  • Details on why EU 536/2014 will require coordinated, detailed global and EMEA planning and management.

Who Should Attend:

  • Sponsor and CRO roles who are responsible for:
    • Clinical development planning
    • Global, EMEA and country project management of studies, process optimization, and operational excellence
    • Country and site identification, selection, study package contracting, and site documentation
    • EMA regulatory submissions
  • US Central IRBs roles who are responsible for generating study content for IRB submission of global studies.

Speakers

Christel Gremion Viatte
Global regulatory CTA team lead
CSL Behring

Christel Gremion Viatte leads currently the Global Regulatory Affairs CTA group at CSL Behring. She has 16 years’ experience in management of global clinical trials and in development of clinical trials regulatory strategy. For the EU Clinical Trial Regulation EU536/2014 she was involved in early testing of the CTIS submission portal and contributed as sponsor representative to EMA stakeholder readiness activities. Since several years, she is actively involved in the workstream getting CSL Behring ready for this regulation. Christel holds a PhD in Immunology and a Regulatory Affairs Certificate in Pharmaceuticals and Medical Devices from the RAPS University.

Craig Elliott
General Manager, European Operations
IQVIA Biotech

Dr. Craig Elliott is the General Manager for European Operations at IQVIA Biotech with over 30 years of experience in the pharmaceutical industry, working across all phases of clinical development and on global projects. He has worked within numerous global clinical operation functions, performance management and process improvement groups in both large pharmaceutical and small, medium, and large CRO companies. His therapeutic area experience includes Psychiatry, Alzheimer’s disease, Epilepsy, Parkinson’s Disease, Stroke, Oncology, Infectious Diseases, Transplantation, Diabetes, Gastroenterology, immunology, Nutrition, and rare diseases.
Craig holds a PhD in Respiratory Physiology from Newcastle University.

Aparna Mulupuru
Senior Manager- Management Consulting
Accenture

Aparna is a Senior Manager with Accenture's Life Sciences Strategy & Consulting practice, where she combines her passion for enabling New Science with solutions for improving patient outcomes. She is an R&D enthusiast with over 11 years of experience working with Biopharma companies to identify opportunities for process and technology transformations across the value chain.

John Popp
Senior Consultant, Life Science & Healthcare
Deloitte Netherlands- Risk Advisory

John is a consultant in the life science & healthcare team within Deloitte Netherlands focusing on the regulatory aspect of clinical trials. Over the last years, John has supported a number of international pharmaceutical companies defining and executing optimal strategies for CTR implementation and clinical trial management through CTIS. Prior to that, John has spent 10 years in academic research, as a result of which he holds a PhD in chemistry from Leipzig University.

Thomas Hagemeijer
Healthcare Lead
TLGG Consulting

Thomas has gained years of experience in strategies and business models as a management consultant at A.T. Kearney. As a Frenchman who studied in Spain, worked in Australia and lives in Berlin with his Italian wife, Thomas always brings his perspective as a "Millennial", "European citizen" and "digital expert" to his work. He joined TLGG Consulting in 2017 and works on the healthcare system of the future with a focus on Germany and Europe. His mission is to transform the healthcare system from a "sick-care system" to a "well-care system" by building bridges between all stakeholders in the healthcare system: patients, doctors, payers, policy makers, but also innovators like start-ups or technology companies. He is a sought-after expert and speaker on topics related to the "future of healthcare".

Elvin Thalund
Director, Industry Strategy
Oracle Health Sciences

Elvin is a recognized industry expert in clinical trials, having over 20 years of experience working as a clinical business analyst consultant at major pharmaceutical companies, including, Hoffmann-La Roche and Johnson & Johnson. Elvin works as a product strategist and system architect in Oracle Health Sciences effort to optimize Study Startup. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a master of science in industrial engineering from Aalborg Universitet.

Register Free: https://www.pharmexec.com/pe_w/revolutionize