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Virtual

Dec 11, 2025 12:00 PM - Dec 11, 2025 1:00 PM

(US Eastern Standard Time)

DIA Direct: Clinical Trials Regulation (EU) 536/2014: A Missed Opportunity? Assessing the Impact on EU Competitiveness in Global R&D Clinical Trials

Analyze the Clinical Trials Regulation 536/2014 and its impact on the European Union’s global clinical research.

Presenters

Agnieszka  Skoczylas

Agnieszka Skoczylas

Director, Feasibility & Proposals, Country Manager – Poland, Medpace, Poland

Vladimir  Misik

Vladimir Misik

LongTaal – Clinical Trial Informatics, Partner and Founder, United States

Vladimir has more than 30 years of experience in biomedical R&D, with roles spanning from research scientist at the George Washington University School of Medicine, Fogarty Fellow at the National Cancer Institute NIH, Bethesda, Maryland, to multiple senior roles at Quintiles (IQVIA), including VP and Head of Global Operations Center, Global leadership team member, Regional VP for CEE and MENA, partner and co-founder of VIARES Academy, a clinical trial informatics company, CEO at SanaClis, a full service global specialty CRO.

Kamila  Novak, MSc

Kamila Novak, MSc

Principal, KAN Consulting MON. I.K.E., Greece

Kamila Novak holds MSc in molecular genetics. She has been involved in clinical research since 1995, having worked in various positions in pharma and CROs. Since 2010, she has been working as an independent consultant and incorporated in 2019. Her business activities include auditing, SME consulting for QMS establishment and process improvements, medical writing, and training. Kamila is a certified Lead Auditor for ISO 9001, ISO 31000, ISO 13485, and ISO 15189, a trained auditor for ISO 14155, cGMP-QMS, and GXP. She is a member of the EMWA, the DIA, the CPD UK, the SQA, the Association for GXP Excellence, the WMDO, and other professional societies. In the SQA, she is the Chair of the Beyond Compliance Specialty Section.

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