Risk Management Plan Summit -

Risk Management Plan Summit
11–12 October 2017
London, United Kingdom

Plan, Implement and Execute Compliant RMPs that Improve Patient Safety

Faculty – Risk Management Plan Summit

Stacy Cooper Bailey, Ph.D., MPH
Assistant Professor, Division of Pharmaceutical Outcomes and Policy, UNC ESHELMAN SCHOOL OF PHARMACY

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Stacy Cooper Bailey focuses on the definition and measurement of health literacy, its extent and associations with various health outcomes, and the testing of innovative and viable ‘low-literacy’ intervention strategies to help individuals promote, protect, and manage their health. Her research experience and interests extend across the contexts of disease prevention, medication safety and adherence, and chronic disease management. Bailey’s work also focuses on the broader theme of health inequalities, especially those experienced by immigrant groups and individuals with limited English proficiency.

Carla Perdun Barrett
Executive Director, Global Risk Management, ALLERGAN

Budhesh Dhamija
Senior Regulatory Affairs Professional — Victoza Team, NOVO NORDISK

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Budhesh Dhamija is currently working in Regulatory Affairs department of Novo Nordisk A/S in Copenhagen, Denmark since the beginning of 2017. His main responsibilities include to plan, coordinate and execute the regulatory tasks as required in the projects; including RA submission plans for activities such as variations, line extensions, PSURs, RMPs, and renewals.

Budhesh was previously employed in the Safety Surveillance Department of Novo Nordisk. His main responsibilities included providing process expertise on PSUR/DSUR preparations, training and cross-project alignment of aggregate reporting. He has authored several regulatory PSURs, DSURs and clinical RMPs according to the defined development milestones or as required by Health Authorities. Additionally, Budhesh was responsible for surveillance of Novo Nordisk products during post-approval phases based on safety information from worldwide sources and communication of drug safety issues internally and to health authorities as required.

Budhesh has a Masters of Pharmacy (M Pharm) and a Post Graduate Diploma in Advanced Clinical Research and possesses more than nine years’ experience in the pharmaceutical industry for several therapeutic areas like Diabetes, Cardiovascular, Oncology, and Central Nervous System. Prior to joining Safety Novo Nordisk in 2013, Budhesh was working in a CRO as a Team Leader for Medical writing.

Ruth Dixon
Director, Safety Evaluation and Risk Management, GLAXOSMITHKLINE

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Ruth Dixon has over 20 years experience in the pharmaceutical industry within clinical development and pharmacovigilance roles at major pharmaceutical companies and at a large global CRO. She qualified in medicine from the University of Leeds, UK and as well as BSc, MB, ChB, her qualifications include MRCP, Diploma in Pharmaceutical Medicine and the Diploma in Clinical Pharmacology from the Society of Apothecaries of London. Currently, she is a medical director at GSK within the Global Clinical Safety and Pharmacovigilance Department, a role which includes leadership of global risk management planning processes. She is a Fellow of the Faculty of Pharmaceutical Medicine, an appraiser for medical revalidation and a long-standing member of the Board of Examiners of the Faculty of Pharmaceutical Medicine.

Jane Feron
Risk Management Director, ASTRAZENECA

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Jane Feron, BSc (Hons) has 20 years experience in Pharmacovigilance at AstraZeneca, having previously worked in clinical development. Jane worked in safety surveillance before becoming the process owner for Risk Management and subsequently taking the lead role responsible for all Pharmacovigilance processes. Currently, she is a Risk Management Director and is responsible for developing risk minimisation strategies for the oncology portfolio, supporting affiliates in the implementation of local risk management regulations and risk minimisation measures, and maintaining global oversight of risk management activities internally and externally. Jane has recently been responsible for the implementation and rollout of GVP Rev 2 within AstraZeneca.

Michael von Forstner
Co-Chair, Pharmacovigilance Working Group, MEDICINES FOR EUROPE

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Dr. Michael von Forstner serves as co-chair of Medicine for Europe’s Pharmacovigilance Working Group and is also Managing Director and Head of Risk Management and Pharmacoepidemiology at Mesama Consulting. Michael’s primary activities are in areas of planning, development, implementation and evaluation of (benefit-)risk management solutions, as well as the optimization of processes around benefit-risk management. He is developing and applying (benefit-)risk analysis methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development and implementation of additional risk minimization and PV measures in the context of RMPs, and is involved in teaching and training activities on pharmacovigilance and pharmacoepidemiology at various European institutions. Michael is former Global Head of Pharmacovigilance at Acino Pharma in Switzerland, where his key responsibility was the creation and maintenance of a compliant global PV system.

Before entering his current role, Dr. Forstner was Head of Regional Pharmacovigilance Europe at Boehringer-Ingelheim. His main focus at BI had been to establish a proactive and highly integrated benefit-risk management organization with strong links to other functions, while maintaining compliance with all local regulations in the 35 countries of his region.

From 2009 to 2013, he was Process Development Leader in Drug Safety and Chair of the global Risk Management Working Group at Roche, Basel, where he was — amongst other duties — responsible for all aspects of global benefit-risk management planning and implementation of RMPs

Prior to this he worked in a variety of positions in pharmaceutical R&D at Pharmacia (Nerviano, Italy) and Novartis (Basel, Switzerland), focusing mostly on signal transduction pathways in oncology and CNS disorders, and in drug liability risk management at Zurich Financial Services. He studied biochemistry and medicine in Graz, Austria; holds a Ph.D. in biochemistry from the Swiss Federal Institute of Technology (ETH) Zurich, Switzerland; did postdoctoral work at UC Berkeley/Lawrence Livermore National Laboratory, California in the area of structural enzymology and biophysics; and was Assistant Professor of Molecular Structural Biology at Sveriges Lantbruksuniversitetet in Uppsala, Sweden. Recently, he also obtained a postgraduate certificate in pharmacovigilance and pharmacoepidemiology from the London School of Hygiene and Tropical Medicine.

In his spare time, Michael loves to spend time outdoors with his children and dogs, and to engage in various activities from skiing and hiking to fishing, hunting, horseback riding and gardening. He is also an avid reader, and loves the opera and music in general.

Matthias Hoffman
Senior Risk Management & Epidemiology Specialist, MUNDIPHARMA RESEARCH GMBH & CO KG

Emanuel Lohrmann

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After studying medicine, Emanuel Lohrmann worked in Drug Discovery at Bayer Healthcare and later switched to the Drug Safety Department at Bayer in 2005. He started as Drug Safety Scientist. Later he assumed responsibility for the risk management of a product in late-stage clinical development. In 2007, he became the Safety Risk Management Therapeutic Area Head in the Drug Safety Department at Bayer (TA Cardiovascular) within Global Drug Safety, responsible for the risk management of cardiovascular products under development and on the market. In 2010, he joined CSL Behring as Head of the Risk Management Group within Global Drug Safety. He joined Merck KGaA (Darmstadt) in 2013 as head of Global Drug Safety Science and Epidemiology, responsible for the pharmaco-epidemiology group in Global Drug Safety and the implementation of methods to improve signal management and benefit-risk assessment of products under development and post-approval. Since 2015 he is Lead Risk Management Physician at Boehringer Ingelheim.

Sumit Munjal
Senior Medical Director, EU+ Marketed Products, Global Pharmacovigilance, TAKEDA PHARMACEUTICALS

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Dr. Sumit Munjal, a physician by training and an Indian by background has been associated with

  • Academic organizations such as London School of Hygiene & Tropical Medicine, Faculty of Pharmaceutical Medicine of the Royal College of Physicians and Drug Safety Research Unit, Southampton;
  • Government organizations such as National Health Service, England, and MHRA;
  • and Pharmaceutical industry such as Johnson & Johnson, Millennium Oncology Pharmaceuticals Inc, Nycomed and Takeda Pharmaceuticals.

He is keen and remains committed to promote public health, patient safety and meet healthcare needs around the globe. He is currently based out of Takeda Pharmaceuticals, Central London, UK.

Annalisa Rubino
Senior Research Scientist, EVIDERA

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Annalisa has over 20 years of experience in drug development within the academic, government, and industry environments. At Evidera she works in the Real-World Evidence group, providing expertise in observational studies and therapeutic risk management, including post-authorization safety studies (PASS) and risk minimization interventions.

Before joining Evidera, Annalisa worked in the consultancy sector on complex drug safety studies and overall safety strategies for risk management purposes. From 2010 to 2015 Annalisa was a scientific administrator at the European Medicines Agency (EMA), leading the development of guidelines on therapeutic risk minimization. In her earlier academic career, she was a principal investigator at the University College London (UK), where she was awarded several prestigious fellowships and grants.

Annalisa has published more than 50 peer-reviewed articles, including papers on high-impact journals (e.g., BMJ, Trends in Pharmacological Sciences), and is an experienced speaker at international conferences.

Annalisa holds a Ph.D. in pharmacology from the University of Florence (Italy) and a master’s degree in epidemiology from the London School of Hygiene and Tropical Medicine, London (UK).

Marcus Schartau
Safety Surveillance Risk Management Specialist, NOVO NORDISK

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Marcus Schartau is the Safety Surveillance Risk Management Specialist at Novo Nordisk A/S. In his role, Marcus is responsible for all processes associated with risk management activities anchored in Global Safety, for assessing new risk management requirements and assisting the local affiliates in interpreting and fulfilling local requirements.

He also contributes to the development of global and local risk management and risk minimisation activities. This includes guiding the initial discussions relating to risk management during early development, supporting the preparation of risk management plans for market authorisation applications and providing guidance to the subsequent updates taking place thereafter. As part of his role, he maintains a global overview of risk management and risk minimisation activities across the world.

Marcus has a PhD in Zoological Cell Biology from Lund University and has been working with pharmacovigilance at Novo Nordisk A/S since 2011.

Paul Sheehan
Executive Director, Head of U.S. REMS, CELGENE CORPORATION

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Paul Sheehan, BSc (Hons), CPHIMS, joined Celgene Corporation in 2005, and is currently the Head of the U.S. REMS department where he is responsible for the design, implementation and maintenance of Celgene’s REMS programs for REVLIMID, POMALYST and THALOMID. Paul has 17 years of experience working in the pharmaceutical risk management industry, and previously was the head of global risk management operations at Pharmion, and a consultant at SI International who designed, developed and managed risk management programs for Roche, BMS and GSK among others. Paul holds a BSc (Hons) Information Systems Management from Bournemouth University, England, is completing his Masters of Science in Jurisprudence from Seton Hall University School of Law, and is a Certified Professional in Health Information and Management Systems. Paul has co-authored a number of articles about pharmaceutical risk management, and presented at international conferences about the subject.

Kandra Weller
Global Head of RMP Office, NOVARTIS

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I have worked in the pharmaceutical industry since 2000, mostly in Pharmacovigilance.

I have been with Novartis for about 14 yrs in both Training Dept and Pharmacovigilance, and in the Head of RMP Office position since 2015.

Michael Wolf, Ph.D., MPH
Professor, Medicine and Learning Sciences, Associate Chair, Department of Medicine, Associate Division Chief, Research, General Internal Medicine and Geriatrics, FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY

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Dr. Michael Wolf is a Professor within the Feinberg School of Medicine at Northwestern University. He serves as Associate Division Chief for General Internal Medicine and is the Associate Chair-Research for the Department of Medicine. In 2004, Dr. Wolf founded the Health Literacy & Learning Program (known as HeLP). Its goal is to make meaningful changes in the way healthcare is delivered in order to confuse patients less. His team of researchers currently lead several National Institutes for Health (NIH) – funded studies, many of which are testing ways to help patients better understand their personal health, stay connected with their doctor outside of encounters, and to signal to healthcare providers if a patient needs assistance in self-managing their medical regimen. He has published over 200 peer-reviewed articles on the topic of ‘health literacy’ and deconstructing what it means to be a patient — and more importantly, the unnecessary complexity placed on individuals and families by the healthcare system when attempting to assume that role. Whether it be leveraging new health technologies or simply promoting a better drug container label, Dr. Wolf’s work is all focused on simplifying healthcare for everyone.

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