4th Pharma Pricing, Reimbursement & Market Access 2021

09:30 – Quantitative Drug Safety and Benefit Risk Evaluation - Practical and Cross-Disciplinary Approaches
• Regulatory Landscape and Interdisciplinary Collaboration in Safety Evaluation
• Design and Analysis Considerations in RCT and RWE for Safety Decision Making
• Safety/Benefit-Risk Evaluation and Visualization
• A reflection on an interdisciplinary book project on Safety

WILLIAM WANG, Executive Director, Clinical Safety Statistics, Merck
JUDY LI, Senior Director, Biostatistics Lead, San Diego Site, Bristol-Myers Squibb
MELVIN MUNSAKA, Senior Director, Head Safety Statistics, Abbvie
JIM BUCHANAN, President, Covilance

DATA COLLECTION – MANAGEMENT

10:30 – Panel Discussion - PV Audit & Inspections – Knowing what is to be done
• Data Quality Management and Analysis
• Real world data: are you sure you have the relevant data?
• PV Inspection readiness: What to expect? How ready can we be?
• Risk based selection criteria for auditing
• Methodologies, scope and oversight
• Preparing and managing safety data exchange agreements
• Relationship to other GxPs

Moderator:
KATARINA ILIC, Senior Medical Director, Clinical Sciences, Takeda Pharmaceuticals

Panellists:
RAJ BHOGAL, Senior Director, R&D Audits & Inspections, Jazz Pharmaceuticals
RENA PANDIT, Global Director & Global Patient Safety Head of PV, Compliance and Training, Amgen
JENNIFER KANE, VP, Pharmacovigilance, Flexion Therapeutics
TEA BABIC, Director, PV Audits and Inspections, Teva Pharmaceuticals
NICOLE BAKER, CEO, Biologit
ARUN TIRUMALAI, Sr. Technical Consultant, GSK

11:20 – Morning Coffee/Tea & Discussion

PATIENT SAFETY

11:40 – Keynote Panel Discussion: Pharmacovigilance and Patient Safety
• Driving patient centricity into your PV plans
• Patient Support Program in Pharmacovigilance
• 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
• A practical approach to reshaping patient safety
• Next generation pharmacovigilance for enhanced patient safety

Moderator:
DEEPA VENKATARAMAN, Head of Global Patient Safety and Pharmacovigilance, Summit Therapeutics

Panellists:
SUMIT MUNJAL, Vice President, Global Patient Safety Evaluation, Takeda Pharmaceuticals
JOHN SOLOMON, Head of Pharmacovigilance UK & Ireland, Sanofi
JAMES (JAY) DUHIG, Director, Patient Integration Pharmacovigilance & Patient, Safety (PPS), Abbvie
TANJA PETERS, Head Global Patient Safety Neurology & Immunology, Merck KGaA
KAVYA KADAM, Consultant Global Clinical Trials

12:30 – Developing a Pharmacogenomics & Biobanking Program
DINA AVERY, Assistant Professor & Director of Research Operations, University of Alabama at Birmingham, School of Nursing

13:00 – Networking luncheon

RISK MANAGEMENT & PLANNING

13:50 – Panel Discussion – PV – Risk Management and Planning
• Risk management in the lifecycle of a drug
• How effective is your risk management?
• Challenges and overcoming problems in Pharmaceutical product life cycle management
• Implementation and maintenance of RMP’s – Overcoming its challenges
• Development and Operations of REMS – Challenges and Mitigations
• Risk management in different jurisdictions
• Benefit/Risk ratio: the common denominator
• New approaches to managing benefit-risk
• Research and development improvement

Moderator:
BEN LOCWIN, Executive SME, Black Diamond Networks

Panellists:
CARMIT STRAUSS, Global Safety Director (Benefit Risk Management Officer), Amgen
KAL ELHOREGY, Director, Risk Evaluation and Mitigation Strategy (REMS) Programs, Amneal Pharmaceuticals
MOHAMED ABDILLAHI, Director, Risk management Product Lead, Pfizer
NANCY DUBOIS, Associate Director, Local Safety Officer, US Region, Alexion Pharmaceuticals
OYINKANSOLA ODEBO, Assistant Director, Drug Safety Clinical Research, Supernus Pharmaceuticals
KATARINA ILIC, Senior Medical Director, Clinical Sciences, Takeda Pharmaceuticals

REGULATION OVERVIEW & UPDATE

14:40 – Panel Discussion: PV - Regulatory Updates
• Key current changes and their impact on current PV
• Pharmacovigilance and the role of regulatory affairs: How to achieve compliance across the business
• Future Legislation: Pharmacovigilance – Industry Vision
• PV System Legislation Updates
• Enhancing communication between regulators, regional authorities and patients
• What’s next? Ways to proceed forward.

Moderator:
BEN LOCWIN, Executive SME, Black Diamond Networks

Panellists:
AYSE BAKER, Vice President of Regulatory Affairs, Almatica (Alvogen)
MICHAEL BEAN, Senior Director, BioResearch Regulatory Compliance, Johnson & Johnson
KENNETH LIPETZ, Associate Director - PV operations, Project Management, Moderna
MARJAN DZEPAROSKI, RA and PV Manager, Bionika Pharmaceuticals
ALEXANDER ROUSSANOV, International Partner, Arnold & Porter

15:30 - Afternoon Tea/Coffee

15:50 - What are the benefits of applying AI for medical literature monitoring?
• Are sources important?
• Are search strings redundant?
• How can you validate AI?

NICOLE BAKER, CEO, Biologit

PRE-CLINICAL & CLINICAL TRIALS

16:20 – Merging adverse events throughout clinical trials and post marketing surveillance
• Building the continuum of pharmacovigilance across pre-marketing and post-marketing
• Emerging challenges to monitoring adverse drug events in clinical trials
• Establishing key performance indicators for making timely safety reports and continuous quality improvements
• Targeted event collection
• Strengthening the link between a drug and its related ad verse events from pre-clinical to post-marketing

GIHAN ATALLA, Vice President, Head of Global Drug Safety &, Pharmacovigilance, Genmab
ABHISHEK PITTI, Associate Director, Global Drug Safety &, Pharmacovigilance Physician, Genmab
MINA EBEID, Associate Director, Drug Safety & Pharmacovigilance, Scientist, Genmab

17:00 – End of the conference