Executve Director, NextPV Services, Czech Republic
Vojtech is a qualified expert in drug safety and pharmacovigilance with extensive experience gained through working on different positions across all PV areas. The wide exposure to global clients (both sponsors and MAHs) has helped him to gain a comprehensive overview of critical PV processes and systems. Vojtech’s main expertise is advance pharmacovigilance consulting, EU QPPV activities, signal management, ICSR management, EudraVigilance support, XEVMPD/ISO IDMP, PV auditing and medical writing.
Calin A. Lungu, MD
CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg
Dr. Lungu has over 30 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted more than 160 Pharmacovigilance quality system audits in more than 40 countries around the globe. Apart of audits, he is a dedicated trainer of the official EMA EudraVigilance and XEVMPD training programmes and led over 300 offerings since 2004.
Pierre-Frederic Omnes, MPharm
Executive Director, Life Sciences, TransPerfect, France
Pierre-Frédéric Omnes recently joined Transperfect Life Sciences & has over 20 years of experience in global CROs and Pharma Companies as Regulatory Affairs consultant, overseeing numerous multinational clinical trial applications globally. He is a subject matter expert on SSU and Regulatory Operations in global clinical trials as well as on the EU CTR 536/2014 for corporate readiness, implementation, EU Portal, transparency. Pierre is part of the EMA-led initiative developing the CTIS as Lead Product Owner representing the Industry & Academia, continuing his engagement of several years in User Acceptance Testings, Workshops and Analysis& Design sessions related to the system development.
Jose Alberto Ayala Ortiz, MPharm, MSc
QPPV, PVpharm, Spain
José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2004, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.
Ruediger Pankow, DrSc
Regulatory Affairs Expert, CTIS SME and PO, Germany
Ruediger Pankow joined Parexel in 2007 in Regulatory Consulting. He is Principal Consultant Regulatory Affairs in the clinical trials regulatory service leadership with responsibility for regulatory process, compliance and policy. As Industry Associations liaison he supports stakeholder initiatives with EU Regulators and EMA on implementation of the EU Clinical Trials Regulation, since 2019 as Sponsor Product Owner in the EMA Clinical Trials Information System (CTIS) delivery project and as EMA/DIA CTIS sponsor user trainer. Ruediger obtained a university degree in Biology in 1995, holds a scientific doctorate degree and was a post-doctoral research scientist prior to joining the CRO business in 2007.
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.