Speakers
Sina Schader, DrMed
Head of QPPV Office and EU QPPV, AbbVie, Germany
Sina is the Head of the QPPV Office & EU QPPV in the department Pharmacovigilance and Patient Safety and located in Germany. She has been with Abbvie 14 years. Prior to joining Abbvie, Sina studied veterinary medicine and wrote her PHD thesis in the Virology department, working group Immunology on bone marrow transplantation. In her free time, Sina loves spending time with her husband and two little girls and enjoys horse-riding.
Sarah Gomersal
GPvP Inspector , Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sarah joined the MHRA GPvP Inspectorate in 2019. During this time she has led a significant number of inspections and been involved in the training of new inspectors. Prior to this, Sarah worked within the MHRA for three years as a Senior Pharmacopoeial Scientist for the British Pharmacopoeia, writing monographs for medicinal chemical products and managing analytical method development with the BP Laboratory in support of the standard setting process. She was also responsible for the preparation of summary reports and recommendations for Expert Advisory Groups and Panels of Experts of the British Pharmacopoeia. Sarah has a First Class Honours degree in Biomedical Sciences from The University of Manchester.
Louise Woodward, PhD
UK QPPV and Local Safety Responsible, Roche Products Ltd, United Kingdom
Louise began her career in pharmacovigilance over 20 years ago and has held a variety of roles, including Safety Advisor and Team Leader within a UK Safety function and Clinical Safety Scientist within a Global Safety department, gaining experience in all aspects of PV. She moved to work with EU QPPV Office roles for over 7 years, as PSMF Manager/Process Owner and also as a PV Governance and Policy Leader. Louise has been the UK Local Safety Responsible for Roche Products Ltd for over a year now and took on the role of UK QPPV in October 2021.
Helen Fiddes
Head of Country Pharmacovigilance, UK and Ireland, Bristol-Myers Squibb, United Kingdom
Helen Fiddes, Head of Patient Safety, UK and Ireland at Bristol-Myers Squibb, based in Uxbridge, United Kingdom. Managing a team of nearly thirty Pharmacovigilance professionals, working on a diverse portfolio including three Pregnancy Prevention Programmes for thalidomide and its derivatives. Been in the industry and pharmacovigilance for over 20 years. Prior to that community pharmacy, after graduating from the University of Strathclyde, in Glasgow.
Elspeth McIntosh, MBA, RN
Director, Castle Pharmacovigilance Ltd, United Kingdom
Elspeth McIntosh began her career in the pharmaceutical industry in 1993, initially working in clinical research, before moving into Pharmacovigilance. She has extensive experience of all aspects of pharmacovigilance and has been a small company QPPV since 1999, dealing with innovative, generic and biotech/biological products. Elspeth set up Castle Pharmacovigilance in 2009 and post Brexit she is a UK QPPV and UK National Contact Person for several small pharma companies and provides general PV support to a wide range of pharma companies.
Amit Aggarwal
Executive Director, Medical Affairs, ABPI, United Kingdom
Amit Aggarwal has over 14 years experience in the pharmaceutical industry, most recently at LEO Pharma as Medical Director for the UK and Ireland. Prior to that he spent over a decade at Bayer where he held various roles including pharmacovigilance, Global medical affairs, and latterly as Director of Medical Affairs UK for General Medicine. His background is as a medic, spending 5 years working clinically in the NHS, mainly in secondary care. Amit has worked on both innovative and established product launches, spanning a range of therapy areas including oncology, women's health, cardiovascular medicine, dermatology and thrombosis in the UK and globally. Amit holds a MA in Neuroscience from the University of Cambridge, and a MBBS from Guy’s,
Phil Tregunno
Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.
Anne Carter
Consultant, Carter & Associates Ltd, United Kingdom
Anne Carter is a contract QPPV (UK and previously EU), UKNCP and provides bespoke PV systems for a number of small pharma companies. Anne began her career in the pharmaceutical industry in 1989 and has experience within regulatory affairs, pharmacovigilance and medical information. Carter & Associates Ltd was founded in 1997 to provide regulatory affairs and pharmacovigilance services primarily but not exclusively to small pharma companies.
Julia Coombes
Unit Manager of the Product Information Quality Unit, MHRA, United Kingdom
Dr Julia Coombes completed her BSc in Physiology and PhD at the University of Edinburgh. Following this, she took up two post-doctoral research positions at the National Institute for Medical Research (NIMR) and St Mary’s Hospital, Paddington. In July 1995 she joined the Medicines and Healthcare products Regulatory Agency as a scientific assessor with the Product Information Quality Unit. She is now the Unit Head, managing a team of three assessors. The team is responsible for the assessment of labels and leaflets for licensed medicines in the UK, in line with current legislative requirements.
Stephanie Millican, PhD, MSc
Deputy Director Benefit Risk Evaluation, Safety and Surveillance, MHRA, United Kingdom
Stephanie is the Deputy Director of Benefit Risk Evaluation II in the Safety and Surveillance group at the MHRA. Prior to her current role she held a variety of management and assessor positions in the Agency. She has a masters degree in Clinical Pharmacology and a PhD in Cell Biology. She joined the Agency following a career in academia and has now over 20 years experience in drug regulation with particular experience in post-authorisation procedures and pharmacovigilance.
Pav Rishiraj
Director and Head of Pharmacovigilance , IPSEN, United Kingdom
As a Senior Pharmacovigilance (PV)/Patient Safety leader and expert with extensive detailed experience spanning 21 years across multiple functions including global/local positions, Pav Rishiraj has held senior management/leadership positions, primarily alongside QPPVs/VPs of PV (and as a UK QPPV), to ensure strict compliance to global regulatory obligations. Pav is currently a Director of PV at Ipsen Biopharma and continues to Chair the ABPI Pharmacovigilance Expert Network (PEN) for over 5 years which has enabled him to influence, shape and advocate the PV landscape from an industry perspective with stakeholders such as the MHRA and the NHS. Furthermore, he is also a serving member of the ABPI Board Steering Group (BSG) representing UK PV.
Cleo Fu
UK QPPV, Alliance Pharmaceuticals Limited, United Kingdom
Himal Makwana
Head of Defective Medicines, MHRA, United Kingdom
David Sulivan
, MHRA, United Kingdom
Liam Deevy
Senior Manager - Global Regulatory Sciences, BMS, Ireland
Liam Deevy is a Senior Manager in Global Regulatory Sciences at BMS with responsibility for regulatory activities in the UK and Ireland for commercial and clinical products within the Innovative Medicines portfolio. He has worked in various positions within the Quality organisation at BMS, supporting manufacturing and product launch activities, including as an EU Qualified Person. He is also a registered pharmacist with the Pharmaceutical Society of Ireland, with prior experience working in hospital and community pharmacy settings. He holds a Postgraduate Diploma in Leadership and Management from University College Dublin and a Master of Pharmacy degree from the Royal College of Surgeons Ireland.
Chia Yin Lim
Patient Safety Partner and Risk Management Plan Implementation Coordinator, Roche Products Ltd, United Kingdom
Chia Yin is currently the Patient Safety Partner and Risk Management Plan Implementation Coordinator in Roche. Chia Yin’s responsibilities include maintaining oversight and ensuring effective implementation of safety risk management strategy. Chia Yin brings experience from the APAC region as she was the Drug Safety Manager in Roche Malaysia, holding the roles as a deputy Local Safety Responsible and RMP IC since 2018. Chia Yin continues to share her passion in the area of pharmacovigilance seeking opportunities in partnering across different functions to advance the impact of pharmacovigilance towards the safe use of medicines. Chia Yin is a pharmacist by training with clinical experiences in primary to tertiary healthcare settings.
Elena Cucu, MS
Deputy EU QPPV, Abbvie, Romania
Elena is the Deputy EU and UK QPPV at Abbvie, located in Romania. Pharmacist by training, she started her pharmacovigilance career more than 14 years ago as Drug Safety Specialist. Following this, she worked in various roles in the risk management field with a focus on risk minimization strategy, development and implementation, having experience with both innovative and established products. Elena also worked in PV Quality Assurance before becoming part of the QPPV Office.
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