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Meeting Speakers from the European Medicines Agency
We are honored to have the European Medicines Agency partner so closely with us, especially at time where innovation has been catalyzed. Learn more below about these leaders of today.
Meet Our Confirmed Speaker from the European Medicines Agency
Priya Bahri, PhD, RPh, Principal Scientific Officer
Priya Bahri, PhD, at EMA since 1996, is now EMA's lead for pharmacovigilance guidelines (EU-GVP) and research into risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. In that role she collaborates closely with patient, healthcare professional, academic and industry organisations as well as WHO and has participated in ICH and CIOMS working groups. She is active in the learned societies ISoP and ISPE and provides lectures and research advice to the Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.
Robert Bream, PhD, MA, MS, Quality Specialist
Rob is a quality specialist in the EMA Quality Office, responsible for quality aspects of new and generic medicinal products from development phase (scientific advice), via initial authorisation (MAA) to post-authorisation (variations, line extensions, referrals). He also coordinates the development of scientific guidelines by the QWP, BWP and EMA PAT Team and is a member of the EDQM CEP Steering Committee. He was an EU expert in the ICH Q11 EWG is currently an EU expert on the ICH Q2/Q14 EWG. He is the EMA quality specialist responsible for nitrosamines. Before joining the EMA, Rob spent 7 years in the pharmaceutical industry as a chemistry project leader, development chemist and medicinal chemist supporting various clinical programs.
Marco Cavaleri, PhD, Head of Biological Health Threats and Vaccines Strategy
Head of Anti-infectives and Vaccines, European Medicines Agency (2009-present)
Therapeutic Group Leader for Anti-infectives, European Medicines Agency (2008-2009)
Associate Scientific Director, Cosmo Pharmaceuticals S.p.A., Lainate, Italy (2008)
Scientific Administrator, European Medicines Agency (2005-2007)
Associate Director of Clinical Pharmacology, Tibotec BVBA, Mechelen, Belgium (2005)
Emer Cooke, MBA, MSc, Chair, ICMRA; Executive Director
Ms Cooke was nominated as Executive Director with a renewable five-year mandate by the Agency’s Management Board on 25 June 2020 and is the first woman at the helm of EMA. "I take up the role of Executive Director of EMA amid a public health crisis of unprecedented scale,” said Emer Cooke on her first day in office. “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to support the development and approval of safe and effective COVID-19 vaccines and treatments.” Ms. Cooke obtained her degree in pharmacy from Trinity College in Dublin, Ireland. She has additional Masters degrees in Science and Business Admin., also from Trinity.
Sabine Haubenreisser, PhD, MSc,
Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held positions at EMA in scientific divisions, international affairs and (currently) stakeholder engagement. She served 5 years as EMA Liaison Official at the US FDA, where she facilitated cooperation between the European Regulatory Network and the FDA. During this time, she oversaw completion of the EU/US Mutual Recognition Agreement on GMP inspections and development of new platforms for cooperation such as on patient engagement, rare diseases and pharmacometrics.
Anabela Marcal, PharmD, EMA Liaison Official to the US FDA
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently Anabela is the EMA Liaison Official to FDA.
Francesco Pignatti, MD, Head of Oncology and Hematology
Andrew Thomson, PhD, MA, MS, Statistician, Methodology Taskforce
Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics subgroup of ICH E11A on pediatric extrapolation. Before joining EMA, he headed the Epidemiology Unit in the Vigilance and Risk Management of Medicines Division of the MHRA, the UK regulator and was also previously a Statistical Assessor within the Licensing Division of the MHRA
Fia Westerholm, DVM, MSc, Programme Assurance Manager
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). Education in veterinary medicine, toxicology, and social sciences. Professional with more than 20 years of experience mostly in private and public sector areas in research and development, assessment, and regulation of medicines as well as management at EU & national level.
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