Conference Program

PV EUROPE 2023

Agenda

15 – 16 May 2024

15 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

Regulatory Affairs Management by Mateja Pranjic | GSK | 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

Platinum Sponsor Speaking Slot

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

GOLD SPONSOR SPEAKING SLOT

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

16 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

SILVER SPONSOR SPEAKING SLOT

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

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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!

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