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Clinical Trial Regulation Conference

This conference provides a forum for information exchange and discussion on conceptual and practical questions about critical issues affecting sponsors and Member States regarding the implemention the regulation.


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, DrSc, PhD

    Surendra Gokhale, DrSc, PhD

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

    Dr. Surendra Gokhale has gained over the past 23 years, extensive experience of EU, US and global regulatory procedures and had several interactions with EMA/CHMP/FDA and other Global regulators. Currently, he is engaged as one of the capability Development leaders in the Global Regulatory at Roche, and also 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 groups. He has represented EFPIA on ICH M5 activity as well as the topic leader on the ICH E6 update activity completed last year. He will be the EFPIA topic lead for recently initiated ICH M11- Clinical electronic Structured Harmonized Protocol (CeSHarP).

  • 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.

  • Judith  Creba, PhD

    Judith Creba, PhD

    • Executive Director, EU Regulatory Strategy
    • 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 co-chair of the EFPIA Clinical Research Expert Group. She is also leading implementation of the new EU clinical trial regulation within Novartis.

  • Esteban  Herrero-Martinez, DrSc, PhD

    Esteban Herrero-Martinez, DrSc, PhD

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

    Previously Director of Regulatory Intelligence and Policy at Daiichi Sankyo Development Ltd, lead for Pharmacovigilance & Regulatory Affairs at the Association of the British Pharmaceutical Industry (ABPI) and Pharmacovigilance Manager at P&G Pharmaceuticals. Education: Biochemistry BSc from Warwick University, Virology PhD from University College London, Virology postdoc at Imperial College London.

  • Merete  Joergensen, MBA, MSc

    Merete Joergensen, MBA, MSc

    • Senior Trial Disclosure Director, Clinical Reporting Anchor & Disclosure
    • Novo Nordisk A/S, 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.

  • Angelika  Joos, MPharm

    Angelika Joos, MPharm

    • Executive Director, Global Regulatory Policy
    • Merck Sharp & Dohme (Europe) Inc., Belgium

    Angelika Joos, MPharm, is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional networks to define policy positions, and informing MSD’s regulatory strategy development. Angelika represents MSD in various Committees of the European Federation of Pharmaceutical Manufacturers and Associations, EuropaBio, and the European Confederation of Pharmaceutical Entrepreneurs; she is also involved in international policy activities as the MSD delegate in the IFPMA Regulatory Science Committee, and the BIO and the PhRMA international Committees.

  • 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 >15 years of global experience in the clinical research arena.

  • Anne  De Bock

    Anne De Bock

    • Sr Regional Director
    • AstraZeneca, Belgium

    Pharmacist with 25 years experience in Regulatory Affairs in Veterinary, Biotech and now in AstraZeneca in Oncology and Infection. Main interest is the European Regulatory environment. Also, over 20 years of experience in trade association work.

  • Isabelle  Clamou

    Isabelle Clamou

    • Regulatory affairs Director - EU Policy
    • Amgen Ltd, Belgium

  • Emma  Du Four, MBA

    Emma Du Four, MBA

    • Head of International Regulatory Policy
    • Abbvie, United Kingdom

    Emma Du Four has extensive global experience in the biopharmaceutical industry encompassing product development, clinical trials, real world evidence, paediatric medicines, biotherapeutics, devices, pharmacovigilance, policy and strategy development. Emma currently serves as Head of International Regulatory Policy at AbbVie, where she is responsible for providing strategic guidance and leadership on regulatory policy issues. Emma holds an Honours degree in BioChemistry, an MBA and is a Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA)

  • Christian  Fulda

    Christian Fulda

    • Lawyer
    • Jones Day, Germany

    Dr. Christian Fulda focuses his practice on the life sciences industry. He has broad experience covering the legal issues that these heavily regulated industries face, including product development and issues related to securing IP rights; entering into development agreements and setting up clinical trials; advising on regulatory questions regarding marketing authorizations, including disclosure of data, and reimbursement; negotiating manufacturing and distribution and related agreements; and advising on day-to-day operations, including advertising regulation, health care compliance, and product liability issues. In addition, Christian has an extensive track record in global dispute matters.

  • Camelia  Mihaescu

    Camelia Mihaescu

    • GCP, GLP and PhV Inspections
    • European Medicines Agency, Netherlands

    Camelia has 15 years of experience working in academia, the pharmaceutical industry and in a regulatory agency, in the fields of regulatory affairs, pharmacovigilance and clinical trials. She is a pharmacist by education and has been working at the European Medicines Agency for almost 5 years. In her role Camelia is responsible for the coordination of GCP and pharmacovigilance inspections, taking part in drafting EU guidelines related to GCP and collaborating with international regulatory agencies on inspectional matters. Camelia has a PhD in Pharmaceutical Sciences.

  • 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.

  • John  Poland, PhD

    John Poland, PhD

    • Regulatory Affairs Consultant
    • Association of Clinical Research Organizations (ACRO), United Kingdom

    John has worked in Regulatory Affairs since 1979 until retiring from Covance, where he had global responsibility for regulatory policy and compliance, in March 2015. John is a former chair of the ACRO European Scientific and Regulatory Committee and now acts as a consultant to ACRO.

  • Adam  Smith

    Adam Smith

    • Development Excellence Leader, Pharma Portfolio Management
    • F. Hoffmann-La Roche Ltd, Switzerland

    Development Excellence Leader (Roche), based in the UK. Specialist in Organisational Change and Development. Trained coach, certified learning and development specialist (CIPD) and practitioner in Change Management (PROSCI).

  • Sini  Eskola, MPharm, MSc

    Sini Eskola, MPharm, MSc

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

    Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014. She leads regulatory policy and advocacy activities on clinical trials and transparency, pharmacovigilance, regulatory information technology and environmental sustainability aspects. She has previously worked over 5 years at AZ R&D Global Regulatory Affairs in Sweden and 3 years as Executive Director of Finnish Pharmacists' Society. She is currently Board member of Industrial Pharmacy Section in FIP.

  • Anne-Sophie  Henry-Eude, PharmD

    Anne-Sophie Henry-Eude, PharmD

    • Head of Documents Access and Publication Service
    • European Medicines Agency, Netherlands

    Anne-Sophie Henry-Eude is a doctor in pharmacy with post-graduate degrees in Regulatory Affairs and Pharmacovigilance & Pharmacoepidemiology. She worked in the pharma industry then joined EMA as product team leader for anti-infectives. She then worked on paediatric investigation plans in the HIV field. In 2013 she became Head of the new Access to Documents Service and with the implementation of the policy on Clinical Data Publication, she is now Head of Documents Access & Publication at EMA.

  • Nicole  Hinton

    Nicole Hinton

    • Associate Director, Clinical Trial Transparency
    • Ultragenyx, United States

  • Elena  Bolanos, PharmD

    Elena Bolanos, PharmD

    • Advisor Global Clinical Operations
    • Eli Lilly SA, Spain

    Elena has more than 24 years experience in drug development and clinical operations. She is responsible for managing the development of the long-range plan for global Clinical Operations and the strategic capabilities required to support delivery of the portfolio, and to enhance the performance of the Clinical Operations organization globally by providing the expertise and experience needed to drive strategy, execution and assure proper controls and resources are in place to ensure effective operations. She represents Lilly in EPFIA Clinical Trials and Transparency Working Group.

  • Mats  Ericson, PhD

    Mats Ericson, PhD

    • Regulatory Affaris Director
    • Amgen France, France

    Mats is a molecular biologist by training and works as Regulatory and R&D policy director at Amgen. He has a background in academic immunology research, company-sponsored clinical development, project management and has for the last ten years been in drug regulatory affairs.

  • Amanda  Joseph

    Amanda Joseph

    • EU Advisor, Clinical Case Management
    • Eli Lilly and Company, United Kingdom

  • Noemi  Manent

    Noemi Manent

    • Scientific Administrator, Compliance and Inspection
    • European Medicines Agency, Netherlands

    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 Isabel Manley, LLM

    Marie Isabel Manley, LLM

    • Partner, Head of the UK Life Sciences
    • Sidley Austin LLP, United Kingdom

    Marie Manley leads is Partner and Head of Sidley’s UK life sciences practice. She is a distinguished thought leader and adviser on EU and UK regulatory law and acts as Chairperson of the DIA Legal Affairs Community. Marie advises clients before both national and European courts and the regulatory agencies in the UK and across Europe. She represents leading pharmaceutical and life sciences companies in litigation before the EU and English Courts, as well as before the national and EU regulatory authorities. Marie features prominently in leading bar publications. She earned a LLM from Columbia University School of Law and from Lausanne University; and a Postgraduate Diploma on EU Competition Law from King’s College.

  • Anastassia   Negrouk

    Anastassia Negrouk

    • Head of International Policy Office, DPO
    • EORTC, Belgium

    Anastassia Negrouk is holding master's degree in Biology, she specialized during 5 years in cellular biology and biochemistry working in a research laboratory focusing on cancer research. She joined EORTC in 2000; Involved in the regulatory since 2003, she took on her current position in 2011.The follow-up and analysis of EU legislation relevant for clinical research is integral part of her work. SInce 2017 she is also a DPO for EORTC.

  • Sandra  Petraglia, MD, PhD

    Sandra Petraglia, MD, PhD

    • Head of Pre Authorisation Department
    • AIFA - Agenzia Italiana Del Farmaco, Italy

    Sandra Petraglia has been working at the AIFA since 2004. Currently Head of Pre Authorisation Department, with close involvement in the national implementation activities and requirements for the Clinical Trials Regulation since 2015, being also the Italian representative at the CTFG and at the EMA and EU Commission groups on implementation of Regulation 536/2014 EU. Medical Doctor by education, Dermatologist and PhD in Dermatological Immunology, her previous activities at the AIFA have been as Clinical assessor, MRP/DCP Coordinator and Italian CMDh member from 2005 to 2016. Previously, she has being working in the fields of Information and Advertising on Medicines and of Dermatological Oncology and Immunological therapy.

  • Richard  Stephens, MA

    Richard Stephens, MA

    • Former Chair, Consumer Forum (Patient Advocates)
    • National Cancer Research Institute (NCRI), United Kingdom

    Richard Stephens has survived two cancers, a heart emergency, and continued co-morbidities and late effects. He has participated in four interventional studies and nine others. He chaired the NCRI Consumer Forum 2012-2019 and now chairs BBMRI-ERIC’s Stakeholder Forum (Europe’s biobanking infrastructure). He sits on strategic groups for NIHR, NHS England, PHE, Genomics England, Cancer Research UK and the ABPI, and works with industry and with patient groups in Canada and Europe. Richard co-authored the UK Cancer Strategy, helped found the AllTrials campaign and useMYdata movement, and is the patient lead for the UK’s Living With And Beyond Cancer research priorities. He is also co-edits the Journal of Research Involvement and Engagement.

  • Janice  Branson, MSc

    Janice Branson, MSc

    • VP Head of Statistics, Immunology & Dermatology Unit
    • Novartis Pharma AG, Switzerland

    Janice Branson is the Statistics Development Head for Immunology and Dermatology in Clinical Development & Analytics at Novartis. She holds a MSc. in Biometry from University of Reading and a BSc. in Mathematics, Statistics and Computer Science. After post graduate studies at University of Reading U.K., Janice joined Pfizer in UK. In 2001. Janice moved to Novartis, Basel taking on a role in the statistics group supporting early development. Over the last years Janice has had increasing roles of responsibility and along with leading the global statistics group for the Immunology and Dermatology Franchise, since early 2013 Janice is the Statistics lead across Novartis on clinical trial data transparency and implementation of Policy 0070.

  • Trish  Groves

    Trish Groves

    • Deputy Editor
    • British Medical Journal, United Kingdom

    Dr Trish Groves trained in medicine and psychiatry before joining The BMJ in 1989, where she is Director of Academic Outreach and Advocacy for BMJ, Editor-in-Chief of the online only journal BMJ Open, and Honorary Deputy Editor of The BMJ. She has published widely, particularly as a coauthor of research reporting guidelines including the CONSORT 2010 statement on clinical trials https://scholar.google.com/citations?user=OMJJMOEAAAAJ&hl=en Trish is currently exploring how BMJ might help to build capabilities for health research in low and middle income countries, and is editorial lead of BMJ’s Research to Publication elearning programme for health researchers.

  • Maja  Leon-Grzymkowska

    Maja Leon-Grzymkowska

    • Legal Officer at European Commission
    • European Commission, Belgium

    Maja León Grzymkowska is the legal officer in the "Medicinal products - quality, safety and innovation" Unit in the Health and Food Safety Directorate General of the European Commission. She holds a PhD in International law from the Jagiellonian University of Cracov. The core of her interest was human rights and bioethics. After working for several years as university researcher and as a civil official in Polish Ombudsman Office, she joined the European Commission in 2008. In the European Commission she has worked on several areas related to the health care. In 2013 she joined DG SANTE dealing in particular with the new Regulation on clinical trials.

  • Martin  O'Kane, RPh

    Martin O'Kane, RPh

    • Head of Clinical Trials Unit
    • MHRA, United Kingdom

  • Speaker  Invited

    Speaker Invited

    • Switzerland

  • Claire  Berry

    Claire Berry

    • F. Hoffmann-La Roche AG, Switzerland

    Claire Berry is a Group Manager in Clinical Trial Regulatory Management at F. Hoffmann-La Roche Ltd. based in Basel, Switzerland. She has been working in Regulatory Affairs for over 12 years and has been involved in the development of a number of drugs from early to late stage across several Therapeutic Areas. Before joining Roche she worked for 3 years in Solvay Pharmaceuticals GmbH (now Abbott). Claire received a Doctor of Veterinary Medicine and has a Master's Degree in Business Administration.

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