Day One World Drug Safety Congress EU 2018

08:00

Registration & refreshments

Susan Welsh
08:50

Chair’s opening remarks

Andrea Best
09:20

Global Clinical Trials and the complexities of Reference Safety Information (RSI)

  • Overview of the changing landscape related to RSI
  • Perspectives on navigating RSI complexities in light of new EU requirements
  • Potential approaches for consideration in context of global clinical trial conduct
10:00

Questions and Answers

10:20

Speed Networking

10:40

Morning refreshments

Bruce Palsulich
11:20

Can PV Keep up with the Pace of Innovation? Exploring the Rapid Evolution of AI in Pharmacovigilance

  • AI for case processing
  • AI applied to signal detection
  • Regulatory considerations
round tables
11:40

Roundtables

Different approaches - signal detection for small to medium companies
Sutirtha Mukhopadhyay

Sutirtha Mukhopadhyay, Associate Director of Pharmacovigilance, Ablynx

Disruption across the PV ecosystem and how the industry stakeholders are adapting
Amanda Bowles

Amanda Bowles, Specialist Leader, Deloitte Consulting LLP

Examining the challenges of updating risk management plans in line with revision II of GVP V
Liana Gross Martirosyan

Liana Gross Martirosyan, Senior Pharmacovigilance Assessor, Dutch Medicines Evaluation Board

Examining the Pharmacovigilance System Masterfile and licensing pharma audit
Monika Manske

Monika Manske, Associate Director of Global Pharmacovigilance Governance, Mylan

Improving local drug safety processes
Miroslava Novakova

Miroslava Novakova, DSM, G.S.K.

Quantitative benefit-risk assessment: where are we today?
Thomas Verstraeten

Thomas Verstraeten, Managing Director, P95

The new eudravigilance: process changes and best practices
Margherita D'Antuono

Margherita D'Antuono, E.U. Q.P.P.V., Italfarmaco

12:30

Networking Lunch

SIGNAL DETECTION & MANAGEMENT

RISK MANAGEMENT

BIG DATA & AI IN SAFETY

SAFETY IN ONCOLOGY

13:30

Chair’s remarks

14:15

TBC

14:55

Afternoon Refreshments

SIGNAL DETECTION & MANAGEMENT

RISK MANAGEMENT & BENEFIT-RISK MANAGEMENT

BIG DATA & AI IN SAFETY

PV OUTSOURCING

15:25

Chair’s remarks

15:50

Partner presentation

16:10

Utilizing Big Data to make benefit-risk decisions

  • What is Big Data?
  • Methods to effectively leverage Big-Data in Safety
  • The role of Big Data for Benefit-Risk decision making
16:30

Innovation in benefit-risk evaluation present and future

  • Among Regulators, HTAs, industry and academia, Benefit-Risk evaluation has shifted into a more structured and quantitative approach
  • The role of patient preference in the medicinal product decision-making, including Benefit-Risk evaluation, has significantly increased
  • Given this shift, various innovative methods of quantitative Benefit-Risk evaluation and patient-preferences have been evaluated in various public-private initiatives
16:50

Afternoon Refreshments

SIGNAL DETECTION & MANAGEMENT

RISK MANAGEMENT

INNOVATION IN SAFETY AND AI

SAFETY FOR ADVANCED THERAPIES

17:45

Partner presentation

18:05

Speaking presentation

18:10

Networking drinks reception

last published: 04/Sep/18 15:35 GMT