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Mercure Amsterdam City Hotel

Nov 07, 2023 8:15 AM - Nov 07, 2023 5:00 PM

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

CTIS Sponsor User Workshop

Ensure Clinical Trial Success: Master Application Functionality and Avoid Withdrawal or Lapses

Speakers

Fatima  Pimentel

Fatima Pimentel

Director, Regulatory Consulting, Syneos Health, Spain

Fatima Pimentel joined Syneos Health in 2021 as an Associate Director, Site Start-Up & Regulatory and is also responsible for the training and development of the new CTIS Portal Team. She worked as a Regulator in the Portuguese Agency INFARMED, I.P, between 2005-2021 in the Clinical Trial Unit, as a senior CT coordinator. Fatima was part of several EMA CT groups as well as CTFG. Fátima studied Industrial Pharmacy and obtained a POS-degree in Clinical trials Monitoring. Joining the EMA-CTIS project almost from start as a MS Product Owner and master trainer. Currently she is a trainer in the EMA/DIA CTIS sponsor trainings.

Ruediger  Pankow, DrSc

Ruediger Pankow, DrSc

Clinical Trial Regulatory Consultant | CTIS SME, Independent Consultant, Germany

Ruediger Pankow holds a university degree in Biology and is a Regulatory Affairs professional with more than 17 years of experience in the clinical research and trials regulatory space, mostly in the CRO industry. His specific area of expertise is the EU Clinical Trials Regulation 536/2014 (EU CTR) and EU CTR implementation at industry level, including for his past employer Parexel. Since 2019 he has been continuously involved for ACRO as an industry stakeholders' representative (sponsor product owner / external SME) in EMA's Clinical Trial Information System (CTIS) delivery project, and is DIA instructor of EMA's CTIS sponsor end user training programme.

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