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Clinical Trial Regulation Conference


Speakers

  • Nick  Sykes, MS

    Nick Sykes, MS

    • Senior Director, Worldwide Safety & Regulatory
    • Pfizer Ltd., United Kingdom

    Currently working in Europe and International regulatory policy and strategy group in Pfizer. Been working for Pfizer for 17 years. My main focus - lead a small team providing regulatory policy and strategy to Pfizer organisation. Previous employment includes SmithKline Beecham, Scrip and Cambridge Antibody Technology

  • Surendra  Gokhale, PhD

    Surendra Gokhale, PhD

    • Senior Director, Global Regulatory Affairs and Capability Development Lead
    • F. Hoffmann-La Roche Ltd, Switzerland

    Dr. Surendra Gokhale has gained over the past 20 years, extensive experience of EU, US and global regulatory procedures and has had several interactions with EMA/CHMP/FDA etc. Currently, he is Roche’s business lead for a cross-functional project to implement the Clinical Trials Regulation in the EU. Since many years he is member of the EFPIA and IFPMA Regulatory group and ICH M5 group and currently member of the EU Clinical Trials subgroup and EFPIA Topic leader on the ICH E6 activity. Global approach for the clinical development keeping in mind the GCP concept and the patient in focus, working for the innovative Industry, finding the alignment between regional regulatory aspects and Global development needs is the main focus of his work.

  • Elke  Stahl, PhD

    Elke Stahl, PhD

    • CTFG Co-Chair; Clinical Trial Unit
    • Federal Institute For Drugs and Medical Devices (BfArM), Germany

    Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany. CoChair of the Clinical Trial Facilitation Group (CTFG) and involved in EMA’s EU CT information system groups as BfArM’s representative. Pre-clinical assessor since 2005. 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.

  • Karina  Griffiths

    Karina Griffiths

    • Director – Clinical Trial Application (CTA) Lead
    • Pfizer Ltd, United Kingdom

  • Merete  Joergensen, MBA, MSc

    Merete Joergensen, MBA, MSc

    • Senior Trial Disclosure Director, Global Clinical Registry
    • Novo Nordisk A/S, Denmark

    Merete Joergensen holds an MSc and an MBA. She has more than 25 years of experince in clinical research from University and Pharmaceutical industry, most recent 7 years within Clinical Trials Disclosure, in Novo Nordisk A/S covering policy, operational processes and www.NovoNordisk-trial.com

  • Robert  Paarlberg, MS

    Robert Paarlberg, MS

    • Principal
    • Paarlberg & Associates LLC, United States

    Robert Paarlberg is the Principal of Paarlberg & Associates LLC, a consultancy specializing in global clinical trial disclosure and regulatory policy/intelligence. Bob is also current Chair of DIA’s Clinical Trial Disclosure Community. Bob has more than 35 years of pharmaceutical industry experience with the vast majority of his experience in US and international regulatory affairs.

  • Matthias  Zerm, PhD

    Matthias Zerm, PhD

    • Lead Expert, Clinical Trial Disclosure and R&D Processes
    • Merz Pharmaceuticals GmbH, Germany

    Matthias Zerm is a Lead Expert Clinical Trial Disclosure and R&D Processes at Merz Pharmaceuticals located in Frankfurt/Germany. In this role he coordinates and oversees all clinical trial disclosure activities including registration and results submissions, training and education, as well as process development. He is also involved in a wide range of organizational and process-related projects at Merz. He is a biologist by training and has 14 years of global experience in the clinical research arena.

  • Noemi  Manent

    Noemi Manent

    • Scientific Administrator, Compliance and Inspection
    • European Medicines Agency, European Union, United Kingdom

    Noémie Manent joined the European Medicines Agency EMA in March 2011 as a Principal Scientific Administrator in the Compliance and Inspection Sector. She is involved in the coordination of EMA Good Clinical Practice (GCP) and pharmacovigilance inspections. She also has a major role in the update of the European Clinical Trial Database (EudraCT) to integrate clinical trial results data to the already established protocol related data and allow for sponsors to publish clinical trial results on the European Clinical Trial Register (www.euclinicaltrialsregister.eu). Currently, she is involved with the implementation of the clinical trial Regulation No. 536/2014 and particularly with the EU portal and database.

  • Marie  Manley, LLM

    Marie Manley, LLM

    • Partner and Head of the Regulatory Practice
    • Bristows LLP, United Kingdom

    Maria Isabel, Partner & Head of the Regulatory Department at Bristows LLP, specialises in European & UK regulatory and competition law in the bio-pharmaceutical and medical devices sectors. Marie advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a bio pharmaceutical business. Marie represents pharma companies before UK and EU institutions (EMA, MHRA, NICE, PMCPA DOH and the European Commission). Marie is Chairperson of the Legal Affairs Community for DIA. She is considered a leading practitioner for regulatory law and is described by clients as a “regulatory superstar”.

  • Elisna  Maree

    Elisna Maree

    • Associate Director - Regulatory Affairs
    • Vectura Limited, United Kingdom

    Elisna has over 15 year experience in regulatory strategy at a number of pharmaceutical companies and is currently an Associate Director at Vectura Limited where her responsibilities include the implementation of the Clinical Trials Regulation within the organisation. In addition her role also includes the development of global regulatory strategies for in-house Phase 1 to 3 development projects, which include start-up, continued support of clinical trials and MAA planning. In order to assess the impact of changes in the regulatory environment on the organisation she also represents Vectura at industry meetings and conferences.

  • Elena  Prokofyeva, MD, PhD, MPH

    Elena Prokofyeva, MD, PhD, MPH

    • Head of Drug Safety Unit, Department of Research & Development, DG PRE
    • Federal Agency for Medicines and Health Products (FAMHP), Belgium

    Dr. Elena Prokofyeva is head of drug safety unit at the Department of Research & Development, DG PRE, the FAMHP, Brussels, Belgium. She represents Belgium within the CTFG safety subgroup. She initiated and led an update of the Q&A-RSI document within the CTFG. Dr. Prokofyeva holds a research doctorate from the University of Tuebingen, Germany, a Ph.D. and an M.D. from the Northern State Medical University, Arkhangelsk, Russia, and a Master of Public Health from the University of Umeå, Sweden. Harmonization of safety assessment across members of states in Europe, preparation for the implementation of a safety related part of clinical trial regulation, and safeguarding the safety of trial participants are main objectives of her work.

  • Sini  Eskola

    Sini Eskola

    • Director, Regulatory Affairs
    • European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium

    Sini is working as Regulatory Affairs Director at European Federation of Pharmaceutical Industries and Associations (EFPIA) since 2014. In EFPIA her main focus areas are leading and coordinating the regulatory policy and advocacy activities on clinical trials and transparency, pharmacovigilance, regulatory information technology and environmental, health and safety aspects. She has previously worked over 5 years at AstraZeneca R&D Global Regulatory Affairs in Sweden and prior to that as an Executive Director of Finnish Pharmacists' Society. Since 2011 she has been a member of the Executive Committee of Industrial Pharmacy Section of International Pharmaceutical Federation.

  • Esteban  Herrero-Martinez, PhD

    Esteban Herrero-Martinez, PhD

    • Director Regulatory Policy and Intelligence
    • Abbvie Ltd, United Kingdom

    Director of Regulatory Intelligence and Policy at Daiichi Sankyo Development Ltd, previously ABPI lead for PV & regulatory. Education & employment history: Biochemistry BSc from Warwick University, Virology PhD from University College London, Virology postdoc at Imperial College London and PV manager at P&G Pharmaceuticals for 5 years.

  • Stéphanie   Kromar

    Stéphanie Kromar

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

    Stéphanie Kromar joined the EORTC in 2013. In 2014, she joined the Regulatory Affairs Department. As Regulatory Affairs Manager, she is responsible for the preparation of CTA and amendments and has experience in various countries. She is providing regulatory advice from study development until the end of trial. She is now also involved in the implementation of the new clinical trials regulation and has been involved in the recent on-site portal testing at EMA.

  • Greet  Musch, PhD

    Greet Musch, PhD

    • General Director, DG Pre-Authorisation
    • Federal Agency for Medicines and Health Products (FAMHP), Belgium

    Mrs Greet Musch obtained a PhD in Pharmaceutical and Biomedical Sciences at the Free University of Brussels. She joined the Pharmaceutical Industry for 8 years where she was 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 a senior quality assessor and assisted in several projects related to EMA/CHMP as well as to Generics. Since 2004 she was in charge of the R&D department within the FAMHP in Belgium. From 2009 she has been designed as Director-general for the DG Pre-authorisation. She is involved in different working groups related to unmet medical need, early access and clinical research in a broad sense.

  • Aleksandar   Rusanov

    Aleksandar Rusanov

    • Legal Adviser
    • European Medicines Agency, European Union, United Kingdom

    Aleksandar Rusanov is a Legal Adviser in the Legal Department of the European Medicines Agency. He is dealing with various legal issues including access to documents, transparency, proactive publication of clinical data, referrals, advanced therapy medicinal products, pharmacovigilance, clinical trials, medical devices, etc. He also appears in Court on behalf of EMA in access to documents cases. Before joining the EMA, Aleksandar was an Associate in a leading international law firm and advised clients on a wide range of matters relating to medicinal products and medical devices. Aleksandar was also seconded to a number of pharmaceutical companies to assist in activities relating to compliance and promotion of medicinal products.

  • Judith  Creba, PhD

    Judith Creba, PhD

    • Executive Director, EU Regulatory Strategy, Regulatory Affairs
    • 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 Liaison and Policy where she has represented Novartis on a number of trade association committees. Judith is currently involved in clinical trials policy and is vice–chair of the EFPIA Clinical Trials and Transparency Priority working group. She is also leading implementation of the new EU clinical trial regulation within Novartis.

  • Leona  Fitzgerald

    Leona Fitzgerald

    • Senior Director, Regulatory Affairs
    • PPD, United Kingdom

  • Anne-Sophie  Henry-Eude, PharmD

    Anne-Sophie Henry-Eude, PharmD

    • Head of Documents Access and Publication Service
    • European Medicines Agency, European Union, United Kingdom

    Anne-Sophie Henry-Eude is a French Doctor in Pharm. with post-grad degrees in Reg affairs and Pharmacovigilance & Pharmacoepidemiology. In 2011, she transferred to the Paed. Office of the Agency as paediatric coordinator working on antivirals, esp. medicinal products to treat and prevent HIV. In 2013, she became the Head of the new Access to Documents Service at EMA. With the implementation of Policy 0070 on Clinical Data Publication, she is now Head of Documents Access & Publication at EMA.

  • Lucie  Kravackova

    Lucie Kravackova

    • Senior Clinical Assessor
    • State Institute for Drug Control (SUKL), Czech Republic

  • Karen  Quigley

    Karen Quigley

    • Clinical Data Publication Manager
    • European Medicines Agency, European Union, United Kingdom

    Dr Karen Quigley has a degree in pharmacy from Trinity College Dublin and a postgraduate Masters in Science degree from the same university specialising in the field of controlled drug delivery and rheology. She subsequently obtained her PhD from the Faculty of Medicine, University of London. Karen joined the EMA 15 years ago working in the areas of mutual recognition, scientific advice, veterinary medicines authorisation and availability of medicines. In 2016 she joined the Clinical Data Publication team working on Policy 0070. Prior to joining the Agency, she worked at the Council of Europe in Strasbourg and with the Health Products Regulatory Agency in Dublin.

  • Michael  Smith

    Michael Smith

    • Quality Strategy Lead
    • Merck Serono Ltd, United Kingdom

    Michael has worked in clinical research for over 20 years at the UK, European and global level, both in pharmaceutical company and CRO environments. For much of that time, whether in operations or QA, his focus has been on compliance. He is currently a Quality Strategy Lead at Merck Serono Ltd. (Merck KGaA) where his responsibilities include Clinical Trials Regulation implementation. He has also been a member of the Research Quality Association GCP Committee since 2009.

  • Monique D. Al

    Monique D. Al

    • Senior Scientific Staff Member
    • Central Committee on Research Involving Human Subjects (CCMO), Netherlands

    Monique Al obtained her degree in Human Nutrition at Wageningen University & Research (1988). Subsequently she received a PhD in Human Biology in September 1994 at the Maastricht University.. After that she worked for several nutritional and pharmaceutical companies in the field of clinical research. In 2001 she started as a scientific staff member at the Central Committee on Research Involving Human Subjects (CCMO) in The Netherlands. Since July 2017 she is team coordinator of the Clinical Trial Office located at the CCMO.

  • Sophia  Mylona

    Sophia Mylona

    • Scientific Administrator, Compliance and Inspection
    • European Medicines Agency, United Kingdom

    Joined the Agency’s in 2007. Coordination of GCP and Pharmacovigilance inspections, scientific secretariat support to the Pharmacovigilance Inspectors Working Group and related subgroups and involvement in the implementation of the new pharmacovigilance legislation. A veterinary surgeon with specialisation in public health, has previously worked in the pharmaceutical industry in the areas of clinical research and development and Regulatory Affairs.

  • Karen  Kiilerich

    Karen Kiilerich

    • Special Legal Consultant
    • The National Committee on Health Research Ethics , Denmark

    Karen Kiilerich is a special legal adviser for The National Committee on Health Research Ethic (NEC) in Denmark. NEC is responsible for coordination of activities in the regional committees, issues guidelines, acting as a board of appeal in connection with findings in the regional committees and assess complex cases of clinical research. Karen has a background as Master of Law from the Faculty of Law, University of Aarhus. Before joining the secretariat of NEC in February 2015, Karen has worked as a legal adviser for the regional committees for the capital region since February 2008. And before that Karen worked in public administration within the area of tax (heavy economic crimes) and duty law.

  • Rose-Marie  Swallow

    Rose-Marie Swallow

    • Senior Manager, EU Regulatory Policy & Intelligence
    • 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.

  • Nektaria  Varela

    Nektaria Varela

    • Lead BA for EMA Technology and Architecture Business Analysis Service
    • European Medicines Agency, United Kingdom