The annual DIA Europe meeting dedicated to the pharmaceutical sector will be held in Vienna from 5th to 7th February 2019: 80 discussion sessions with 300 speakers and more than 35 present Agencies. There will be many topics of the pharmaceutical industry, from clinical development to scientific regulations, from patient engagement to translational medicine, from medical affairs to pharmacovigilance. Right to this last one are dedicated six sessions whose macro theme is “Pharmacovigilance towards 2020 and beyond”, that will take place during the second and third days. Here is the program.

WEDNESDAY 6th FEBRUARY

h.10:45: IMPACT OF PHARMACOVIGILANCE ON PUBLIC HEALTH

Chair
Sabine Straus, MD, PhD, MSc
PRAC Chair, Staff Member, Medicines Evaluation Board (MEB)

Speakers
Maia Uuskula
Head of the Bureau of Pharmacovigilance, State Agency of Medicines

Vicki Edwards, RPh
Vice President, Pharmacovigilance Excellence and QPPV, AbbVie, Inc.

Inge Zomerdijk, MSc
Pharmacovigilance Assessor, Medicines Evaluation Board (MEB)

Marco Greco
President, European Fed. of Crohn’s and Ulcerative Colitis Associations

Valerie Strassmann, PhD, RPh
Pharmacovigilance Assessor, Federal Institute For Drugs and Medical Devices

h.12:00: FORUM ON GLOBAL PHARMACOVIGILANCE

In this session a comparison of safety surveillance in the EU and USA, based on experiences with signal management, an outline of authorities’ expectations to PSURs and an update to the WHO´s Smart Safety Surveillance (3S) strategy will be provided.

Chair
Doris Irene Stenver, MD, MPA
Chief Medical Officer, Danish Medicines Agency

Speakers
Comparison of the Management of Safety Signals between EU and USA for 2017
Arpit Vallabhbhai Vachhani, MD
Senior Drug Safety Physician, APCER Life Sciences

Periodic Safety Reports: What are the Authorities Expectations?
Menno Van Der Elst, PharmD, PhD
Alternate PRAC member, Medicines Evaluation Board

Update on the WHO Triple S Initiative
Shanthi Pal
Group Lead, Medicines Safety, Safety & Vigilance, WHO

 

h.15:15: THE NEW EUDRAVIGILANCE SYSTEM: ONE YEAR AFTER

Chair
Margaret Anne Walters

Speakers
Experience with Reporting and Accessing ICSRs in EV
Margaret Anne Walters
Deputy EU Qualified Person for Pharmacovigilance, Merck, Sharp & Dohme Ltd

Industry Experience with Signalling in EV
David John Lewis, PhD
Global Head of Pharmacovigilance, Senior Visiting Fellow, Univ. of Hertfordshire, Novartis Pharma AG

Panel Discussion
Gaby L. Danan, MD, PhD
Pharmacovigilance Expert, NA

 

THURSDAY 7th FEBRUARY

h.09:15: GVP MODULE V RISK MANAGEMENT PLAN: LESSONS LEARNED ONE YEAR AFTER THE REVISION 2

This session will provide an overview on Risk Management Plan preparation nearly two year after of the implementation of the revision 2 of module V and the updated RMP template. The lessons learned from that change and challenges will be presented and discussed by a panel of experts from industry and regulatory authorities.

Co-Chairs
Francoise Dumas-Sillan
EU QPPV, Pfizer Italy
Sabine Straus, MD, PhD, MSc
PRAC Chair, Staff Member, Medicines Evaluation Board (MEB)

Speakers
Result of the EFPIA Survey on the RMP Implementation
Jane Feron
Risk Management Director, AstraZeneca UK Ltd

Time to Reflect and Build on Experience: Generics Sector View
Susana Almeida, PhD
Clinical Development and Safety Director, Medicines for Europe

 

h.10:45: RISK COMMUNICATION: NEW DIRECTIONS FOR THE FUTURE

Risk communication is an integral component of public health management and need to be continuously updated to meet new and developing demands. When deployed effectively, risk communication is an invaluable tool for engendering trust, protecting organizational value, and helping the public make informed decisions. Conducting risk perception research, addressing the role of trust and having a realistic outlook on the impact of risk communications are crucial considerations in risk communication evolvements for the future. This session aims at discussing implications, insights and key lessons learned from the application of risk communication principles in real-world settings, offering suggestions for risk communication research, policies and strategies.

Chair
Amelia Cupelli

Senior Pharmacovigilance Assessor, PRAC member, AIFA

Speakers
Benefit-Risk Communication: lessons from patients
Dinah Duarte, MSc
Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED

Evaluation of the Impact of Risk Communication on Public’s Risk Perceptions Knowledge, Attitudes, and Behaviors including Compliance (Focus groups, Surveys, and other Experiences)
Peter Mol, PhD, RPh
Member SAWP, Principal Clinical Assessor, Medical Center Groningen

Risk Communication in the European Context, Building on the Best Practice Examples – Lessons from SCOPE Project
Sieta de Vries
PhD, University Medical Centre Groningen

 

h.12:00: CAPACITY BUILDING AND CAPABILITY BUILDING IN PHARMACOVIGILANCE

The session will discuss the importance and components of defining roles and designing a competency framework in a global pharmacovigilance system.

Chair
Shelley Gandhi, MSc
Strategic Advisor, NDA Group

Speakers
Panel discussion
Elizabeth Hancox, DrMed, FFPM
Deputy QPPV and Head of Safety Governance, GSK

Capability ana capacity building, competency model for PV organisation
Preeti Verma, DrMed, MD
AVP, Pharmacovigilance, APCER Life Sciences

Global PV System: what does this mean when preparing for an inspection?
Wendy Huisman, PharmD
Vigifit

In addition to the Concurrent Educational Sessions, the classic 60-75 minute discussion sessions, there are planned:

  • DIAmond Sessions, 90-minute discussions on drug development and access;
  • Content Hubs, 30-minute conversations to deepen the most urgent issues;
  • Spotlight Sessions, 60 minutes in which the exhibitors present their services.

We will be exhibitors this year again. The marketing team will be happy to inform you about how our SafetyDrugs safety database helps your pharmacovigilance processes.
You will find us at booth B05.