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Hilton London Docklands Riverside Hotel

Oct 26, 2018 8:30 AM - Oct 26, 2018 4:30 PM

265 Rotherhithe Street , London, SE16 5HW, United Kingdom

Risk Management and Minimisation Workshop

Interactive format with hands-on discussions and activities related to RMP.

Speakers

Patrick  Batty

Patrick Batty

, Medicines and Healthcare Products Regulatory Agency, United Kingdom

Patrick studied cell biology at the University of Durham and clinical pharmacology at the University of Aberdeen. Since 2008 he has worked at the Medicines and Healthcare products Regulatory Agency (MHRA) in pharmacovigilance roles, with experience in spontaneous reporting, signal detection, and benefit-risk assessment, including risk management and communication work. Since 2017 he has been the UK’s alternate delegate on the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC).

Steve  Mayall, PhD

Steve Mayall, PhD

Director, Huron Consulting Group, United Kingdom

Steve Mayall is a Principal Consultant in Huron’s Life Sciences Practice (formerly known as Pope Woodhead). He has advised a wide variety of global pharmaceutical and biotech companies on benefit-risk management for more than 15 years. Key areas have included developing risk management plans; designing, implementing and evaluating risk minimisation and pharmacovigilance activities; and performing structured benefit-risk assessments.

Jan  Petracek, MD, MSc

Jan Petracek, MD, MSc

CEO, Ivigee, Czech Republic

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

Michael  Forstner, PhD, MPH, MSc

Michael Forstner, PhD, MPH, MSc

Head of Global Safety Science, SOBI, Switzerland

Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis and signal management methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.

Randip  Kahlon

Randip Kahlon

Senior Director, Global Risk Management TA Lead, Bristol Myers Squibb, United Kingdom

Randip Kahlon is the Global Risk Management Therapeutic Area Lead for Oncology at Bristol Myers Squibb, with 20 years experience in pharmacovigilance and risk management. He has co-authored scientific publications on risk minimisation effectiveness evaluation studies and presented on digital approaches for risk minimisation at several external conferences. Randip holds a BSc (Hons) Degree in Medical Biochemistry and Diploma in Professional Development, both from Brunel University London.

Catarina  Martins

Catarina Martins

Group Head RMP, Novartis Pharma AG, Switzerland

Catarina Martins is a Group Head in the Novartis RMP global team, with focus on the Oncology portfolio and advanced therapies (ATMPs). Catarina has worked in pharmacovigilance and risk management since 2010, supporting teams in planning, defining, implementing and evaluating risk minimization activities. Previously, Catarina worked at a national competent authority (INFARMED, Portugal) for 5 years as a GxP Inspector, being member of the EMA GCP/PhV Inspectors’ Working Group. Catarina is a PharmD and currently lives in Basel, Switzerland.

James  Milligan

James Milligan

Vice President Pharmacovigilance and Risk Management, Seqirus UK Limited, United Kingdom

Joined Industry more than 10 years ago after training in hospital medicine and neuro-immunology research in the UK. Interests from clinical practice include cardiology, neurology and rheumatology. Experience covering pharmacovigilance at all stages of lifecycle as well as multiple successful NDA and MAA submissions across major therapy areas. Currently leads a global group of Safety Physicians and Scientists across US and Sweden and covering therapy areas of Respiratory, Inflammation, Autoimmunity, Infection and Vaccines. James is actively involved promoting scientific thinking from basic sciences through to challenges of public health and real-world risk management.

Zuzana  Vinterova, PhD

Zuzana Vinterova, PhD

Strategic Advisor, Medical Writing, PrimeVigilance s.r.o., Czech Republic

Zuzana Vinterova received her PhD in Biochemistry from Charles University in Prague and she worked as a researcher at the Institute of Organic Chemistry and Biochemistry within the Czech Academy of Sciences, focusing on the major virulence factors of pathogenic yeasts (Candida spp.). Zuzana has joined PharmInvent (rebranded to PrimeVigilance in 2018) as a scientific specialist and medical writer and has now over 10 years of experience in medical writing of pharmacovigilance (PSUR/PBRER, DSUR, ACO, RMP) as well as regulatory science documents, needed throughout the full life-cycle of medicinal products.

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