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Nov 18, 2020 1:45 PM - Nov 19, 2020 7:00 PM

(Central Europe Standard Time)

Clinical Trial Regulation Conference


Nick  Sykes, MS

Nick Sykes, MS

Policy Advisor, EFPIA, Belgium

Nick is a Policy Advisor for Regulatory Strategy at EFPIA. Nick’s current focus is on the revision of the general pharmaceutcal legislation, regulatory aspects of the Innovative Health Initiative (IHI), and the interface between the drug, device and diagnostics legislative frameworks in the EU. Prior to working at EFPIA, Nick spent 25 years at Pfizer within their Global Regulatory Sciences team. His last role in Pfizer was as Head of Europe and International Regulatory Policy. In this role he was also Co-Chair of EFPIA's Regulatory Strategy Committee. During 2019 Nick was President of TOPRA and Chairman of TOPRA's Board of Directors. Nick has a graduate degree in Genetics/Microbiology and a master’s degree in Information Science

Elke  Stahl, PhD

Elke Stahl, PhD

Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany

Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany. Clinical Trials Senior Expert. CoChair of the Clinical Trial Facilitation Group (CTFG) till 2022. Involved in EMA’s EU CTIS groups as BfArM’s representative, National Contact Point for the CTR in Germany, representative in European Commissions CT working groups. Prior BfArM 10 years experiences as a pharmacokineticist at Bayer HealthCare AG, Germany, in early research up to candidate selection. PostDoc at Hoffmann-La Roche Inc and University of North Carolina (UNC). Ph.D. in pharmacology and licenced pharmacist.

Rose-Marie  Swallow

Rose-Marie Swallow

Senior Manager, Policy & Research, Bayer Plc., United Kingdom

Rose-Marie joined Bayer in July 2013 and is a Senior Manager in EU Regulatory Policy & Intelligence, with special responsibility for CTR implementation and Transparency within the Company. Rose-Marie came to Bayer with over 20 years EU regulatory experience in both the prescription and non-prescription healthcare sectors gained within a number of large research based Pharmaceutical Companies; as well as having worked as a Senior Regulatory Consultant in a small CRO. Rose-Marie has a BSc (1st class hons) in Chemistry and Biochemistry.

Merete  Joergensen, MBA, MSc

Merete Joergensen, MBA, MSc

Clinical Disclosure and Transparency Expert, Merete-J Consulting, Denmark

Merete Joergensen holds an MSc in Statistics and an MBA in Management of Technology. She has more than 30 years of experience in Clinical Research. From 2004 she has been building up the area of Clinical Trials Disclosure in Novo Nordisk. She is now working as a senior specialist for the area of clinical disclosure. Prior she headed up Biostatistics in Novo Nordisk A/S for 15 years and worked 7 years as a Clinical Statistician at the medical faculty at Copenhagen University. Further she has served as Clinical Trials Transparency pillar lead, under the Clinical Research Expert Group in EFPIA.

Christopher  Price, MA

Christopher Price, MA

Senior Manager, Global Regulatory Oncology, Global Regulatory Affairs, Merck Healthcare, Germany

Christopher Price LLB, MA, MTOPRA is a lawyer and biologist by training, he has built up more than 15 years of EU and global experience in clinical strategy & dossier management in several global biopharma companies and at CROs. As well as oncology, he has experience in antiviral, central nervous system, and immunology therapeutic areas. He has also worked in regulatory project management and eCTD submission management. Chris is a representative on behalf of EFPIA in the Clinical Trials Information System (CTIS) Process Owners group, which is working in close collaboration with the EMA, European Commission and the Member States on developing a fully functional system. Currently chair of the clinical trials special interest network at TOPRA.

Matthias  Zerm, PhD

Matthias Zerm, PhD

Lead Expert, Clinical Trial Disclosure and R&D Processes, Germany

Matthias Zerm is a Lead Expert Clinical Trial Disclosure and R&D Processes at Merz Therapeutics located in Frankfurt/Germany. In this role he coordinates and oversees all clinical trial disclosure activities including registration and results submissions. He is also involved in a wide range of organizational and process-related projects at Merz Therapeutics, such as preparing for the EU-CTR. He is a biologist by training and has >15 years of global experience in the clinical research arena.

Robert  Paarlberg, MS

Robert Paarlberg, MS

Principal, Paarlberg & Associates LLC, United States

Robert Paarlberg is Principal of Paarlberg & Associates LLC, a consultancy specializing in regulatory policy, regulatory intelligence and global clinical trial disclosure strategy and operations. Prior to founding Paarlberg & Associates LLC, Bob worked at Pharmacia (Upjohn) and UCB. Bob is former Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 40 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs. Bob has been active in the clinical trial disclosure and transparency space since 2005.

Elena  Popa, MPharm

Elena Popa, MPharm

Regulatory Policy and Innovation Lead, Bayer, Switzerland

Elena is a pharmacist by training with a master in drug safety and pharmacovigilance. She joined Bayer as a Regulatory Policy & Intelligence Lead and provides direction and development of Regulatory Policy & Intelligence activities supporting Bayer’s pipeline and strategies, with a particular emphasis on the regulatory use and acceptance of RWD/RWE in drug development. Before joining Bayer, Elena was a Senior Manager, Scientific Programmes at Drug Information Association and engaged annually with over 500 stakeholders and volunteers from the entire healthcare ecosystem. In her free time, Elena is passionate about traveling, visiting art museums, painting and watching Formula 1 (#essereFerrari).

Ruediger  Pankow, DrSc

Ruediger Pankow, DrSc

Regulatory Affairs Expert, CTIS SME and PO, Germany

Ruediger holds a university degree in Biology and is a clinical regulatory affairs professional with history of more than 16 years in the CRO industry at Parexel, where he last was Principal Consultant in the clinical trial regulatory services. He was involved in his company's EU Clinical Trials Regulation 536/2014 (EU CTR) readiness implementation, and has contributed for ACRO to EU CTR stakeholder activities with EU Regulators and EMA. Since 2019 he has been a sponsor product owner for ACRO in EMA's Clinical Trials Information System (CTIS) delivery project providing input on design and development of system functionalities and guidance material, and is DIA instructor of EMA's CTIS sponsor user training programme.

Laura  Pioppo, MSc

Laura Pioppo, MSc

Scientific Administrator, CTIS expert, European Medicines Agency, Netherlands

Pharmacist with a Master degree in Pharmacovigilance, working experience at EMA in the Compliance and Inspection department, since 2016 working on the development CTIS and leading on CTIS transparency aspects, EMA liaison at the Clinical Trials Coordination Group (CTCG) and from October 2023 Programme Manager for the ACT EU initiative.

Fergus  Sweeney, PhD

Fergus Sweeney, PhD

Head of Clinical Studies and Manufacturing Task Force, European Medicines Agency, Netherlands

Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing and personal data protection in health research on medicines. He joined the EMA Inspections Service in 1999, and became Head of Compliance and Inspections (2009) and Head of Division Inspections and Human Medicines Pharmacovigilance in 2013 (including Scientific Committee Services from 2016). He has a BA (Physiology 1979) a Dr de 3eme Cycle (cancer biology 1982), and PhD (Pharmacology 1986). Fergus worked in clinical research mainly in QA from 1982 to 1999.

Pieter  Vankeerberghen

Pieter Vankeerberghen

Head of Clinical Trials, European Medicines Agency, Netherlands

Pieter Vankeerberghen studied Industrial Pharmacy, obtained a Ph.D. in Pharmaceutical sciences and holds a master degree in informatics. After working for 4 years in R&D, first in Clinical Data Management and later as project manager in human pharmacology, he joined the Belgian authorities in 2000 leading various projects. From 2016 he led their R&D department for clinical trials and unmet medical need. In this role he was a Member State Product Owner for the CTIS project. Since August 2020, he is head of EMA clinical workstream and CTIS programme manager.

Fia  Westerholm, DVM, MSc

Fia Westerholm, DVM, MSc

Programme Assurance Manager, European Medicines Agency, Netherlands

Programme Assurance Manager in the Clinical Trials Information System (CTIS) programme managed by the European Medicines Agency to enable implementation of the Clinical Trials Regulation (CTR). Educational background and degrees in veterinary medicine, toxicology and social sciences. More than 20 years of experience alternating between private and public sector in the area of medicines, including in research and development, assessment and regulation of medicines as well as management at EU & national level. At EMA since 2005.

Judith  Creba, PhD

Judith Creba, PhD

Sr. Global Program Regulatory Director, Reg Affairs GDD Region EU, Novartis Pharma AG, Switzerland

Judith Creba has many years experience in drug development, regulatory affairs and strategy at Novartis. She has worked in a range of therapeutic areas, including Oncology, Infectious Diseases, and Cardiovascular, before moving into EU Regulatory Policy where she has represented Novartis on a number of trade association committees. Judith is currently involved in clinical trials policy and is co-chair of the EFPIA Clinical Research Expert Group. She is also leading implementation of the new EU clinical trial regulation within Novartis.

Marieke  Meulemans

Marieke Meulemans

Founder & CEO, GCP Central, Netherlands

Marieke Meulemans is the CEO of GCP Central B.V. GCP Central was responsible for the development of the Clinical Trial Regulation (ECTR) Training for the Netherlands, commissioned by the Dutch Clinical Research Foundation (DCRF). The modules concern the Submission and Review process of the CTR and include high-level instructions on the functionalities of the CTIS. With almost 20 years of experience in clinical research, she is capable of combining her expertise in training needs analysis, online regulatory training development and her knowledge of clinical research.

Greet  Musch, PhD

Greet Musch, PhD

strategic adviser , FAMHP, Belgium

Mrs Greet Musch obtained a PhD in Pharmaceutical & Biomedical Sciences @ Free University Brussels. She joined the Pharma Industry for 8 years as responsible for all the chemical and pharmaceutical analytical activities related to the development of new innovative drugs . She moved to the Federal Public Health services as senior quality assessor. Since Aug 2004 she was in charge of the R&D department. On Feb 2009 she has been designed as Director-general for the DG Pre-authorisation in the FAMHP.

Andrea  Seidel-Glaetzer, MA, RN

Andrea Seidel-Glaetzer, MA, RN

Head of Project Management , Coordination Centre For Clinical Trials Heidelberg (KKS), Germany

Prior to joining the University Hospital Heidelberg (KKS) 10 years ago, she gained some years’ experience in the pharmaceutical industry. KKS acts with more than 80 staff members as a kind of CRO and provides services to support mainly investigator initiated clinical trials in academic institutions, but also for smaller industries. Since March 2020 Andrea joins EMA´s Clinical Trial Information System testing as a representative of the academia on behalf of the German KKS-Network. This is an association of 26 clinical trial centers, all located at medical faculties and university hospitals with the common task to strengthen activities in clinical trials.

Ann Marie  Janson Lang, DrMed, MD, PhD

Ann Marie Janson Lang, DrMed, MD, PhD

Expert, Assoc Prof, Swedish Medical Products Agency, Sweden

Pierre-Frederic  Omnes, MPharm

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.

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.

Kristof  Bonnarens, MPharm

Kristof Bonnarens, MPharm

Policy Officer Pharmaceuticals, European Commission, Belgium

Kristof is an industrial pharmacist. Being a Belgian national, he started working for the Belgian Federal Agency of Medicines and Health Products in 2005, and in 2009 he took up the responsibility for the Research and Development division, in charge of clinical trial applications. He was the Belgian member and secretary of the Clinical Trial Facilitation Group, and the Belgian representative in the European Commissions Clinical Trial Expert Group. He was also part of the negotiations of the Clinical Trial Regulation in 2013 and 2014. After a brief period working for the association of the Belgian pharmaceutical industry from 2016 onwards, he joined the EU Commission in 2019.

Stéphanie   Kromar

Stéphanie Kromar

Senior Regulatory Affairs Manager, European Organisation for Research and Treatment of Cancer (EORTC) , Belgium

Stéphanie Kromar joined the European Organisation For Research And Treatment Of Cancer (EORTC) in 2013. Since September 2022, she is the Head of the Regulatory Affairs department. She has experience in the preparation, submission, and follow-up of Clinical Trials Applications from the development until the end of the trial, on complex trial designs and she provides regulatory advice. She has an in-depth knowledge of the CT Regulation, was involved in the CTIS project almost since the beginning and she also took part to the review of the CTIS training material.

Lene Grejs  Petersen

Lene Grejs Petersen

Senior Adviser, Clinical Trials, Danish Medicines Agency, Denmark

Lene Grejs Petersen is Senior Adviser at the Danish Medicines Agency, Clinical Trial Unit. Lene has been member of the Clinical Trials Facilitation Group (CTFG) member since 2008 and the Danish representative of the EU Commission’s expert group concerning clinical trials since 2001. Lene has been an employee at the Danish Medicines Agency since 2000 and she is involved in the implementation of the EU Clinical Trials Regulation into Danish legislation and works as a regulatory assessor and coordinator of clinical trial applications including VHP. Lene has a background as Master in Pharmacy.

Sameer  Sharma, MPharm

Sameer Sharma, MPharm

Associate Director, Clinical Trial Transparency, Merck KGaA, Germany

Sameer Sharma works as a Clinical Trial Transparency Manager at Merck KGaA, Darmstadt, Germany since 2015. He has 10+ years of experience in the Clinical Trial Transparency and Medical Writing domain. At Merck, he is responsible for setting up the processes and overseeing redactions and anonymizations as per worldwide redaction regulations not limited to EMA policy 0070, Health Canada-PRCI, Japan PMDA, EMA Policy 0043, and ad hoc redaction requests. He holds a Masters in Pharmaceutical science and a registered Pharmacist.

Claudia  Riedel

Claudia Riedel

Head of the Clinical Trial Unit, Division of Scientific Services, Federal Institute for Drugs and Medicinal Devices (BfArM), Germany

Stefan  Strasser, MD

Stefan Strasser, MD

Head of Clinical Trials, Institute Surveillance, AGES, Austria

Stefan Strasser trained as a medical doctor at the University of Innsbruck in Austria. He joined the Austrian Medicines and Medical Devices Agency in 2009 as a clinical assessor. His special interest are the regulatory and process aspects of clinical trials with medicinal products, medical devices and IVDs as well as their interfaces (combination products and combination trials). He is a member of several working groups of the EC and the EMA, including the CT Experts Group on Clinical Trials, the Clinical Trials Facilitation Group and the EUDAMED CI/PS WG. Since 2019 he is the head of the department of clinical trials and responsible for the implementation of the various regulations (CTR, MDR and IVDR) regarding clinical trials.

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