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 | R&D Business Strategy and Operations Lead | 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: Shelley Gandhi, Pippa Biswas, Mircea Ciuca
14:45 – 15:15 PM
Evaluating Regulatory Assessment of Risk Management Strategies by the EMA and FDA by Robert Massouh, Head of Risk Management and Benefit-Risk Evaluation, GSK.
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
Avoiding Unintentional AE’s in Market Research by 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
Signal Management in Clinical Development by 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: Pav Rishiraj, Pippa Biswas, Mircea Ciuca
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
Licence Partner Auditing by Andrew Cooper, PV QA Director, GSK
15:15 – 15:45 PM
Afternoon Tea/ Refreshments Networking Break/ Exhibition
15:45 – 16:15 PM
“Pushing PV to the next era” by Ricarda Tiemeyer, Head of Pharmacovigilance, Biogen.
16:15 – 16:45 PM
Round Table Hot off the Press Discussion
16:45 – 17:00 PM
Closing Remarks & End of Conference
Trusted hands behind us
DOWNLOAD THE BROCHURE
Our global upcoming event in Pharmacovigilance has a great line up of Industry speakers and Hot Off the press topics. After witnessing outstanding success in our previous PV conferences, we are delighted to host PV Europe 2022. Click “DOWNLOAD BROCHURE” to download the agenda!
International Delegate Registrations From Across The Globe
