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Virtual

Nov 21, 2024 1:30 PM - Nov 21, 2024 5:30 PM

(Central Europe Standard Time)

EMA Risk Management Information Day

The focus of this interactive Information Day will be to exchange first experiences on the implementation of the revised GVP module XVI guideline on risk minimisation measures from different stakeholders' perspectives.

Faculty

Ulla  Wändel Liminga, DrMed, MS, RPh

Ulla Wändel Liminga, DrMed, MS, RPh

Scientific Director Pharmacology/Toxicology, Medical Products Agency (MPA), Sweden

Dr Ulla Wändel Liminga is a pharmacist, and has a Doctoral thesis in Medical Sciences from Uppsala University in Sweden. In 1994, she started at the Medical Products Agency (MPA), Sweden, as a non-clinical assessor. She has since then worked with non-clinical as well as clinical efficacy and safety assessments. In 2007, she became Scientific director pharmacology and toxicology at the MPA, and in March 2020, her position has changed to Scientific director pharmacovigilance. From July 2012, she has been one of the Swedish members of the Pharmacovigilance Risk Assessment Committee (PRAC) at the European Medicines Agency.

Sabine  Straus, MD, PhD, MSc

Sabine Straus, MD, PhD, MSc

Former PRAC Chair, Medicines Evaluation Board (MEB), Netherlands

Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in the Netherlands since 1997, where she started as an Assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry, her last job as Medical Director at Searle Monsanto in the Netherlands. She was the Dutch member in the Pharmacovigilance Risk Assessment Committee (PRAC) from 2012 till 2018 and acted as PRAC chair from July 2018 till July 2024. She also holds a position as associate professor at the Erasmus Medical Center, department of Medical Informatics in Rotterdam. Her main research focus is on additional risk minimisation, pregnancy prevention programs, biologicals, signal detection and signal management.

Georgy  Genov, MD

Georgy Genov, MD

Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department, European Medicines Agency, Netherlands

Dr Georgy Genov is the Head of Pharmacovigilance Office, within Quality and Safety of Medicines Department, European Medicines Agency (EMA). The office oversees and manages lifecycle pharmacovigilance activities in the EU, including signal detection and management; evaluates the impact of regulatory interventions and develops pharmacovigilance guidelines and standards; ensures leadership, coordination and clear roles and responsibilities for a quality assured EMA’s and EU pharmacovigilance systems; collaborates closely with EMA scientific committees and working parties, in particular the Pharmacovigilance Risk Assessment Committee (PRAC). Oversees the development and maintenance of IT systems for pharmacovigilance.

Priya  Bahri, PhD, RPh

Priya Bahri, PhD, RPh

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research", published in 2020.

Harshil  Patel, MPharm

Harshil Patel, MPharm

Senior Manager AR&RM – RMP, Novartis , India

Harshil Patel is a highly experienced professional specializing in drug safety and risk management, currently holding the position of Senior Manager AR&RM – RMP at Novartis in Hyderabad, India. With over 13 years of expertise, he has demonstrated proficiency in pharmacovigilance program strategy, risk management, aggregate reports, and QPPV oversight activities. He is actively engaged in developing high-quality RMPs with robust strategies and is keen on exploring innovative digital and automated solutions. Harshil holds a Master of Pharmacy from JSS University, India, along with additional certification in Clinical Pharmacology.

Thomas  Goedecke, PharmD, PhD

Thomas Goedecke, PharmD, PhD

Senior Pharmacovigilance Specialist, European Medicines Agency, Netherlands

Since joining EMA in 2006, Thomas Goedecke has worked in all major areas of pharmacovigilance. His roles encompassed data collection and management in EudraVigilance, risk management for authorized medicines, with a focus on medication errors. Since 2015, he spearheads the implementation of the PRAC Impact Strategy,coordinating impact assessments and regulatory research for the European medicines regulatory network. He has contributed to the ENCePP Methods Guide and GVP guidelines on RMM effectiveness evaluation. Additionally, he oversees medication error reporting guidelines.

Luvanka Kalliopi  Hanxhari

Luvanka Kalliopi Hanxhari

Senior Manager AR&RM – RMP, Novartis, Switzerland

Luvanka is an accomplished professional with 20+ years in the pharmaceutical industry. She is an expert in Safety Risk Management currently serving as a Senior Manager AR&RM – RMP at Novartis in Basel, CH. Her 15-year career at Novartis includes key positions such as Deputy Head of Risk Management Office, Global RMP Lead, and Global RMP Manager. She also worked locally as Medical Information Manager, Medical Resource & Process Manager, and Local RMP Manager in Greece and Cyprus. Her top interest is the digital dissemination of RMP Educational Materials, and she is currently pursuing a Doctorate in this area. Luvanka holds an MBA from ALBA Business School and a PharmD from the University of Athens.

Liana  Martirosyan

Liana Martirosyan

PRAC Member and PRAC Vice-Chair, Medicines Evaluation Board (MEB), Netherlands

Liana Martirosyan has been with Medicines Evaluation board since 2012 in the field of pharmacovigilance. Since 2008 she is the alternate PRAC member from the Netherlands. Liana is a medical doctor and holds MPH degree and PhD in pharmacoepidemiology. Special interests of Liana include interventions in clinical practice to minimize the drug safety risks and evaluation of additional risk minimization measures’ effectiveness.

Robert  Massouh, MPharm, RPh

Robert Massouh, MPharm, RPh

Head of (Safety) Risk Management and Benefit/Risk Evaluation, GSK, United Kingdom

Rob Massouh, is the Head of Safety (PV) Risk Management and Benefit-Risk Evaluation at GSK. In this role, he serves as the subject matter expert in risk management strategy and benefit-risk evaluation. Rob was previously at the MHRA working as a Scientific Assessor within the Benefit Risk Management Group. Rob is a registered Pharmacist and received his MPharm at the University of Manchester.

Vicki  Edwards, RPh

Vicki Edwards, RPh

Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom

Vicki, a qualified pharmacist, began her career in hospital pharmacy and later specialized in Drug Information Services, setting up Kuwait's first National Drug Information Centre. After returning to the UK and spending four years in community pharmacy, she transitioned to pharmacovigilance, joining Abbott as EU QPPV in 2005. She stepped down as AbbVie EU QPPV in 2018 due to Brexit. Now, as Head of PV Excellence and International QPPV, Vicki oversees the QPPV Office, Global Safety Compliance, and Risk Management. She is passionate about pharmacovigilance and developing teams.

Roberto  Frontini

Roberto Frontini

Former Director of Pharmacy, Centre for Patient Safety Leipzig, Germany

Roberto studied Pharmacy in Hamburg from 1983 to 1988 and obtained his PhD in 1993. After working as a hospital pharmacist in Lübeck and Cologne, he was from 2001 to 2017 Director of Pharmacy, Qualified Person and lecturer on Pharmacoepidemiology at the University Hospital of Leipzig as well as Director for Patient Care at the Centre for Patient Safety. From 2015 to 2017 he was a board member and from 2009 to 2015 the president of the European Association of Hospital Pharmacists (EAHP). He is member of PRAC at EMA.

Viola  Macolic Sarinic, DrSc, MD, MSc

Viola Macolic Sarinic, DrSc, MD, MSc

PRAC Scientific Lead, European Medicines Agency, Netherlands

Viola Macolic Sarinic is a medical doctor, clinical pharmacologist by specialisation who holds a PhD in Pharmacogenomics applied to Biosciences and a master’s in Clinical pharmacology (pharmacokinetics). More than 20 years’ experience as a clinical pharmacologist and pharmacovigilance specialist, both in university hospital and in the medicines regulatory authority in Croatia working at the positions of a clinical and pharmacovigilance assessor, head of the PV department, national PRAC and CHMP member at the European medicines agency (EMA) and served for four years as the director of the Croatian medicines agency (HALMED). Currently at EMA as the PRAC Scientific Committee Lead and Scientific adviser on safety of medicines in the PV office.

Ryan  Marshall

Ryan Marshall

Associate Director, Risk Management, AstraZeneca, United Kingdom

Ryan has over 10 years’ experience in the field of patient safety and medicines development, in both CRO and big pharma environments, encompassing clinical and post-marketing products across a broad range of therapeutic areas. Most recently, Ryan has specialised in risk management implementation, successfully leading and coordinating complex global risk management strategies including digital elements to plan.

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.

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