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

11:20

TBC - Bruce Palsulich Oracle

round tables
11:40

Roundtables

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

Sutirtha Mukhopadhyay, Associate Director of Pharmacovigilance, Ablynx

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

Liana Gross Martirosyan, 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

How to manage a pharmacovigilance crisis in the XXI century?
Ramon Lopez

Ramon Lopez, Head of Clinical Development and Regulatory, Thrombotargets

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, P-95

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

13:35

“Orphanizing” NSCLC: Subsetting for more targeted, more effective and less toxic therapies: EGFR and ALK

  • Chemotherapy for NSCLC
  • NSCLC subsets (EGFR and ALK)
  • Targeted therapy for NSCLC subsets:  efficacy, toxicity, class effects 
13:55

Reserved for UBC

13:55

Reserved for Aris Global

13:55

Partner presentation

14:15

TBC

14:35

Speaker Presentation

14:55

Afternoon Refreshments

SIGNAL DETECTION & MANAGEMENT

RISK MANAGEMENT & BENEFIT-RISK MANAGEMENT

BIG DATA & AI IN SAFETY

PV OUTSOURCING

15:50

Partner presentation

15:50

Partner presentation

15:50

Partner presentation

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

17:20

Chair’s remarks

Haris Shaikh, Senior Director Pharmacovigilance, Orchard Therapeutics
17:45

Partner presentation

17:45

Partner presentation

17:45

Partner presentation

18:05

Speaking presentation

18:25

Networking drinks reception

last published: 23/May/18 13:45 GMT