27th Pharmacovigilance 2022

PV FOR 2022

09:40 – Pharmacovigilance in 2022
• Future horizons and efficiencies in data acquisition, evaluation and risk management
• Future-proofing Safety Systems
• Where are we?
• Boldly Shaping the Future

MIRCEA CIUCA, Global Therapeutic Area Head - Global Clinical Safety and, Pharmacovigilance, CSL Behring

10:20 – Global Safety impacts due to combination products
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen (USA)

11:00 – Morning Coffee/Tea

PATIENT SAFETY

11:20 – Keynote Panel Discussion: Prioritising Patients -Reshaping patient safety
• Developing COVID treatment in the midst of the pandemic: Protecting patients and pharmacovigilance compliance in extraordinary circumstances
• Driving patient centricity into your PV plans
• Pharmacovigilance as a tool for safety and monitoring
• Patient-Perspectives in benefit-risk assessments
• A review of general issues and the specific challenges with patients
• Next generation pharmacovigilance for enhanced patient safety

Moderator:
MIRCEA CIUCA, Global Therapeutic Area Head - Global Clinical Safety and, Pharmacovigilance, CSL Behring

Panellists:
KHAUDEJA BANO, Vice President, Combination Product Quality, Amgen (USA)
JOHN SOLOMON, Head of Pharmacovigilance - UK & Ireland, Sanofi
JAMES WHITEHEAD, Director and Team Lead - Patient Safety Medical Devices &, Digital Health, AstraZeneca
SHAANTANU DONDE, Head of Portfolio Management Team - Medical Affairs, Viatris

12:10 - The globalization of medicines: how to ensure global risk management strategies and ensure safe use by patients worldwide
• The globalization of regulation paving the way to implementation of transnational risk management strategies
• How the practice of medicine and the healthcare provider-patient interactions have transformed across the globe, allowing for better access to global safety data, to be used when developing risk management plans
• One RMP to fit all or all to fit within one RMP: core RMP and how to make good use of this internal tool

ALINA TUDOR, Senior Director, Pharmacovigilance, Kyowa Kirin International

12:40 – Networking luncheon

RISK MANAGEMENT & PLANNING

13:30 – Panel Discussion – Risk Management Plan and, Pharmacovigilance System - New Paradigm
• Implementation of complex risk minimisation measures
• Challenges and overcoming problems in Pharmaceutical product life cycle management
• Managing risks / Administrating risks – Right way in handling situations
• Tailored approaches towards benefit-risk evaluations
• Implementation and maintenance of RMP’s
• Risk management in different jurisdictions
• New approaches to managing benefit-risk

Moderator:
AMGAD SHEBL, Sr. Director, Global Safety Lead, Immunology Global, Clinical Safety & PV, CSL Behring

Panellists:
RUDI SCHEERLINCK, Strategic Safety Lead, Merck Group
MOHAMED ABDILLAHI, Director, Risk management Product Lead, Pfizer
RICARDA TIEMEYER, Country Head of PV (DACH), Biogen
MINHAJ OBEIDULLAH, Head Compliance & Risk Management, Novartis
SANDY EISEN, Chief Medical Officer, Frontline Pharma Consulting

ENSURING COMPLIANCE

14:20 – Remote audits and inspections
• Logistical issues
• How to prepare and what to expect
• Differences from onsite

TEA BABIC, Director – PV Audits and Inspections, Teva

15:00 - Afternoon Tea/Coffee

15:20 – Panel Discussion - Pharmacovigilance Audits: Keeping on the right side of inspectors
• Managing Pharmacovigilance Audits and Inspections
• Data Quality Management and Analysis
• PV Inspection readiness: What to expect? How ready can we be?
• Risk based selection criteria for auditing
• Methodologies, scope and oversight

Moderator:
RAJ BHOGAL, Senior Director, R&D Audits & Inspections, Jazz Pharmaceuticals

Panellists:
TEA BABIC, Director – PV Audits and Inspections, Teva
MOIN DON, CEO, PVCON Consulting, Lead S Asia Chapter, ISoP, Member of Central Advisory Committee, DIA
DNYANESHWAR SANAP, EU/UK QPPV, Head Regional PV and Global Compliance, & Training, Glenmark
RANJANA KHANNA, Former Director & Head Pharmacovigilance Quality, Assurance, Vifor Pharma

15:30 - Afternoon Tea/Coffee

REGULATION OVERVIEW & UPDATE

16:10 – Panel Discussion: PV - Regulatory Updates
• PV System Legislation Updates
• Key current changes and their impact on current PV
• Brexit – Regulatory aspect
• Future Legislation: Pharmacovigilance – Industry Vision
• Enhancing communication between regulators, regional authorities and patients

Moderator:
RISHI CHOPRA, Senior Director, Head of International PV | Deputy EU UK, QPPV, Biogen

Panellists:
PAV RISHIRAJ, Director – Pharmacovigilance (UK & Ireland) & ABPI PV, Expert Chair, Ipsen
KLAUDIJA MARIJANOVIC BARAC, Sr. Director, Global Patient Safety & PV - TPC, Teva
ALEXANDER ROUSSANOV, International Partner, Life Sciences and Privacy, Arnold & Porter

17:00 - 17:10 – End of the conference