How to Avoid Significant Delays in Multi-country Studies Due to EU 536/2014 Clinical Trial Regulation

Life Sciences, Clinical Trials, Pharmaceutical Regulation,
  • Thursday, January 27, 2022

Until now, most tasks required to start enrolling patients could largely be planned and managed independently, with minimal coordination between study, country and site project managers. The focus has been on the first activities required (e.g., first country and site approved), knowing additional activities will follow. This has allowed decentralized, unsophisticated planning and management, with only oversight responsibilities for global and EMEA project managers.

EU 536/2014 represents a paradigm shift to last country and site ready, with any missing content required for the study, country, or site approval delaying all countries and sites. These omissions can impact the overall study timelines by months.

As of January 2023, EU 536/2014 requires all new studies to be submitted under the Clinical Trial Regulation and to use the Clinical Trials Information System (CTIS) for submissions — which means that all countries and sites needed for large multi-country studies must be identified prior to July 2022. Project planning and management roles and systems must be implemented, or large multi-country studies run a significant risk of incurring months of delay.

Join this webinar to explore:

  • Why EU 536/2014 will require coordinated, detailed global and EMEA planning and management.
  • What are the most critical business roles to ensure study success with EU 536/2014 Clinical Trial Regulation?
  • Which study activities and content are most likely to be on the critical path for EU submissions?
  • How to use machine learning to do accurate submission prediction.
  • How to ensure ongoing progress to identify critical process bottlenecks.


Pierre Omnes, Syneos Health

Pierre Omnes, Executive Director, SSU and Regulatory, Syneos Health

Pierre-Frédéric Omnes, Executive Director (Site Start Up & Regulatory) at Syneos Health, has 19 years of experience in global clinical research organizations and pharma as a regulatory affairs consultant. In the last 14 years, Pierre supported the coordination, support and oversight of numerous multinational clinical trial applications globally (Americas, APAC and EMEA) for New Chemical Entities, Biologics and Advanced Therapies across several therapeutic areas.

Pierre is a subject matter expert on the EU Clinical Trial Regulation and supports Syneos Health’s and other sponsors’ readiness activities in that capacity since the publication of the Regulation and beginning of the user acceptance testing of the Clinical Trial Information System (CTIS) back in 2015. Since July 2019, Pierre contributes to the European Medicines Agency-led initiative developing CTIS as Sponsor Lead Product Owner, representing the industry and academia stakeholders on that project.

Message Presenter
Marieke Meulemans, GCP Central B.V.

Marieke Meulemans, CEO & Founder, GCP Central B.V.

Marieke Meulemans founded GCP Central in 2012 and is the driving force behind the company’s powerful vision. She has a master’s degree in health sciences, and almost 20 years of experience in the life science industry, including her work for top 50 Pharma companies, CROs and training academic hospitals in clinical research. Marieke has strong regulatory knowledge and combines this with her expertise in strategic learning management and innovative online learning methods. She is keen on supporting both local and global initiatives with her expertise and is member of the EMA CTIS Training Expert Group of EMA and EUCROF Events and Training Working group. Marieke is part of the EU CTR Steering Group of the Netherlands, responsible for national EU CTR implementation.

It is Marieke’s mission to make clinical research knowledge a core part of everyday practice and improving the quality of research.

Message Presenter
Paulien Nuyts, Deloitte

Paulien Nuyts, Junior Manager Regulatory Risk LS&HC, Deloitte

Paulien is a Junior Manager at Deloitte Risk Advisory in the Netherlands focusing on the Life Sciences and Health Care sector. Over the past two years, she has been involved in various projects within the CTR/CTIS space both from the sponsor as well as authority perspective. She has supported clients in realizing large CTR/CTIS implementation programmes to ensure they are ready come go-live on January 31st, 2022. She has also provided various CTR/CTIS workshops at pharmaceutical companies as well as academic medical centres in the Netherlands.

Message Presenter
Leona Fitzgerald, PPD; ACRO committee member

Leona Fitzgerald, Executive Director Regulatory Affairs, PPD, part of Thermo Fisher Scientific, ACRO committee member

As executive director of regulatory affairs, Leona Fitzgerald, PhD, reviews and provides technical advice to prepare regulatory submissions. She guides internal and external clients to determine the most appropriate regulatory and product development strategies and ensures quality performance for key projects.

Dr. Fitzgerald joined PPD in 2005 as a regulatory affairs executive and has held various roles leading teams providing regulatory and clinical development expertise in oncology, biosimilars, vaccines, decentralised trials and process improvement across all phases of clinical development with extensive experience in rare diseases including orphan designation and protocol assistance. Prior to PPD, she worked in regulatory affairs at pharmaceutical companies, including 3M Healthcare covering responsibility for their inhalation portfolio and Mayne Pharma covering Marketing Authorisation Application planning, submission, and lifecycle maintenance of a portfolio of generic oncology products, anti-infectives and cytotoxic companions.

Dr. Fitzgerald earned her doctorate in medicinal chemistry from the University of Nottingham, and her bachelor’s degree in pharmacology from Portsmouth University, both in the United Kingdom.

Message Presenter
Sylvia Marecki, EMD Serono, Inc

Sylvia Marecki, Director, Operational Design Lead, Operational Designs & Strategy, EMD Serono, Inc

Sylvia Marecki serves as a thought partner to EMD Serono study teams, leading advanced analytics efforts within the Operational Design Center that inform study design optimization and operational planning decisions. Prior to joining EMD Serono in 2019, Sylvia spent over 15 years leading development and commercialization of intelligence solutions and services at Citeline/Informa Pharma Intelligence, Decision Resources Group (now Clarivate), and TriNetX, empowering data-driven decisions across clinical and commercial functions. She received her Doctorate in Pathology and Immunology from Boston University School of Medicine.​

Message Presenter
Elvin Thalund, Oracle Health Sciences

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, supporting their effort to optimize study start up. Elvin is the co-chair on the TMF Reference Model Exchange Mechanism and holds a master of science in industrial engineering from Aalborg Universitet.

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Who Should Attend?

Sponsor and contract research organization (CRO) roles who are responsible for:

  • Clinical development planning
  • Country and site identification, selection, study package contracting and site documentation
  • Global, EMEA and country project management of studies, process optimization and operational excellence
  • EMA regulatory submissions

What You Will Learn

Register for this webinar to learn:

  • Why EU 536/2014 will require coordinated, detailed global and EMEA planning and management.
  • What are the most critical business roles to ensure study success with EU 536/2014 Clinical Trial Regulation?
  • Which study activities and content are most likely to be on the critical path for EU submissions?
  • How to use machine learning to do accurate submission prediction.
  • How to ensure ongoing progress to identify critical process bottlenecks.

Xtalks Partner

Oracle Health Sciences

As a leader in Life Sciences cloud technology, Oracle Health Sciences’ Clinical One and Safety One are trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance. With over 20 years’ experience, Oracle Health Sciences is committed to supporting clinical development, delivering innovation to accelerate advancements, and empowering the Life Sciences industry to improve patient outcomes. Oracle Health Sciences. For life.

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