In a changing and expanding world, this is still the only forum designed for QPPVs by QPPVs, now in its 14th year and still going strong.
The QPPV Forum focuses on international QPs’ role and gives a high-level approach to the discussed topics and continues to identify key trends requiring QPPV awareness, input and oversight. This year’s objectives are built on past successes and have been shaped by valuable feedback provided by participants of the past thirteen meetings, plus many years of QPPV and Regulator interaction at this Forum. Moreover, we are looking forward to receiving information and discuss pragmatic approaches on the modern technology and how this will impact the QPPV Role.
This year we will be focusing more on scanning the horizon and check the opportunities and considerations for QPPV role regarding AI, with the hope to demystify AI for QPPV.
Over time, one of the key successes of the Forum has been the ability to secure the continuing support and involvement of key regulators. Sessions have been open and interactive with attendees appreciating opportunities to raise challenging issues in an informal environment. The 14th QPPV Forum continues this successful approach.
• Modern Technology and AI in Pharmacovigilance: opportunities and considerations for QPPVs
• Business Partners Oversight
• Inspections and Audits
• The QPPV Role in Manufacturing and Quality Issues
• Signal Management
• Measuring Effectiveness of aRMM
Who should attend?
• Pharmacovigilance Consultants
• Directors of Pharmacovigilance Oversight and Standards
• Drug Safety Managers/Leaders
• Medical and Regulatory Affairs Experts
• Aspiring PV Specialists/QPPVs
• Explore long term PV visions, future directions of the ‘PV world’, and potential impact on the role of the QPPV
• Network with colleagues and meet regulators
• Learn from and share experience and ideas with like-minded QPPVs in a neutral environment
• Better understand regulatory and inspectorate expectations globally
• Examine current challenges and share potential solutions
Vicki Edwards, RPh • Vice President, Pharmacovigilance Excellence and QPPV
AbbVie, Inc., United Kingdom
Willemijn van der Spuij, MSc • Exec. Director International World Wide Patient Safety, Europe
Bristol-Myers Squibb, Switzerland
Shahinaz Badr • Regional Pharmacovigilance Manager - Africa, Middle East and Turkey
Newbridge Pharmaceuticals, United Arab Emirates
Peter De Veene, MD • QPPV
Gemma Jimenez Sese • Head of Corporate Drug Safety, EUQPPV
ALMIRALL, S.A., Spain
Maarten Lagendijk, MSc • EU QPPV Deputy
Merck Sharp + Dohme B.V., Netherlands
Elspeth McIntosh • Director
Castle Pharmacovigilance Ltd, United Kingdom
Mette Stockner, MD • Senior Pharmacovigilance Director
Savara ApS, Denmark
Doris Irene Stenver, MD, MPA • Independent Pharmacovigilance Adviser
Unique Advice, Denmark
Katarzyna Swiderek, MPharm, RPh • Acting Manager, Safety Evaluation Risk Management (SERM)
Kiernan Trevett, MSc • Expert Pharmacovigilance Inspector
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Nicolas Tsiakkas, MD • Scientific Director
Nicolas Tsiakkas & Co OE VAT Nr EL099974907, Greece
Angela Van Der Salm, DrSc, PhD • Director Pharmacovigilance
DADA Consultancy, Netherlands
Magnus Ysander, MD • EU QPPV & Head Pharmacovigilance Excellence
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