PV EUROPE 2023
Agenda
24 – 25 May 2023
24 May – Day One Agenda
8:30 – 9:30 AM
Registrations & Refreshments
9:30 – 9:45 AM
Welcome & Chairperson Opening Remarks by Dr. Susan Welsh, SVP, Pharmacovigilance & Chief Safety Officer, Mirati Therapeutics Inc, USA
9:45 – 10:15 AM
A virtuous or vicious triangle: investigation into the relationship between pharmacovigilance, regulatory affairs and quality by Jackie Roberts | Senior Director Regulatory Affairs and UK-QPPV | Accord Healthcare | UK
10:15 – 10:45 AM
PV Audit and Inspections by Raj Bhogal | Senior Director, R&D Audits & Inspections | Jazz Pharmaceuticals | UK
10:45 – 11:15 AM
Case Processing or Signal detection – which is the most important part of Pharmacovigilance? by Graeme Ladds, CEO, Pharsafer, UK.
11:15 – 11:45 AM
Tea/Coffee/ Refreshments Networking Break & Exhibition
11:45 – 12:15 PM
Challenges with implementation of a global PV System while remaining compliant with global regulations by Michael Bean, Senior Director, Johnson & Johnson, UK.
12:15 – 12:45 PM
Safety Connect – Transforming our vigilance system capability by Tahira Jan – Vigilance Collaborations Lead, Medicines and Healthcare products Regulatory Agency
12:45 – 13:15 PM
Advancing Drug Safety with AI Innovation by Jane Reed– Director of Life Science, IQVIA NLP.
13:15 – 13:45 PM
Networking Luncheon
13:45 – 14:45 PM
Panel Discussion : Future of Pharmacovigilance
Moderator: Pav Rishiraj, Director – Head of Pharmacovigilance, Ipsen Biopharma
Panelists: TBC
14:45 – 15:15 PM
Evaluating Regulatory Assessment of Risk Management Strategies by the EMA and FDA by Robert Massouh, Director- Risk Management Product Lead, Pfizer.
15:15 – 15:45 PM
Afternoon Tea/ Refreshments Networking Break/ Exhibition
15:45 – 16:15 PM
Pharmacogenomics in PV : Practical Implications – Giovanni Furlann, World Safety Site Lead, Pfizer
16:15 – 16:45 PM
Topic TBC Dawn Mucci, Jazz Pharmaceuticals, USA.
16:45 – 17:45 PM
Chairperson Closing Remarks & Networking Drinks Reception
25 May – Day Two Agenda
08:30 – 9:15 AM
Registrations & Refreshments
09:15 – 9:30 AM
Welcome & Chairperson Opening Remarks by Dr. Susan Welsh, SVP, Pharmacovigilance & Chief Safety Officer, Mirati Therapeutics Inc, USA
9:30 – 10:00 AM
Implementation of Risk Measures by Emmanuel Lohrmann, Lead Saftety Physician, Otsuka Pharmaceuticals GMBH
10:00 – 10:30 AM
Topic: TBC Mircea Ciuca, Global Therapeutic Area Head- GCSP, CSL Behring, Switzerland.
10:30 – 11:00 AM
Detection, Assessment and Management of Suspected Acute Drug Induced Liver Injury During Clinical Trials by Anna Fettiplace, Senior Director, Patient Safety Oncology, Astra Zeneca
11:00 – 11:15 AM
Tea/Coffee/ Refreshments Networking Break & Exhibition
11:15 – 11:45 AM
Precision pharmacovigilance- benefits and challenges Petar Gjorgiev, Safety Risk Lead, Medical Director, Pfizer.
11:45 – 12:15 PM
Navigating the Latest Regulations for Pharmacovigilance in China by Marylene Zhan, Senior consultant at Accestra Consulting, China.
• Understanding China’s Pharmacovigilance Framework
• What’s new in China’s GVP policies?
• What are the GVP requirements in China?
• Navigating China’s GVP Requirements: Key Strategies and Practices
• Q&A
12:15 – 13:15 PM
Panel Discussion : Patient Support Programs, Medication Errors, Off Label Drug Usage
Moderator: Shelley Gandhi, Director – Pharmacovigilance and Drug Safety
Panelists: TBC
13:15 – 14:15 PM
Networking Luncheon
14:15 – 14:45 PM
“Inspections: The good, the bad, and the things no one tells you!” by Mijal Chavda, Global Head of GxP Inspections & GVP Quality | Senior Director, Global Audits and R&D Quality, Kyowa Kirin.
14:45 – 15:15 PM
“Pushing PV to the next era” by Ricarda Tiemeyer, Head of Pharmacovigilance, Biogen.
15:15 – 15:30 PM
Afternoon Tea/ Refreshments Networking Break/ Exhibition
15:30 – 16:15 PM
Round Table Hot off the Press Discussion
16:15 – 16:30 PM
Closing Remarks & End of Conference
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International Delegate Registrations From Across The Globe
