Day Two World Drug Safety Congress EU 2018

Susan Welsh
08:55

Chair’s opening remarks

Stewart Geary
09:00

Post-Marketing Observational Studies for Pharmacovigilance in Asia: Opportunities, Issues and Management

09:20

Platinum Sponsor TBC

Shinobu Uzu
09:40

Database studies: Using electric medical records in Japan

10:00

The pharmacovigilance landscape for low and middle-income countries: The Bill & Melinda Gates Foundation perspective

10:20

Morning refreshments

round tables
11:10

Roundtables

Achieving effective safety standards during inspections
Lykke Bjerglund Graff

Lykke Bjerglund Graff, Head of Global Pharmacovigilance, LEO Pharma

Establishing PV agreement in low and middle income countries
Nadia Espanol

Nadia Espanol, Senior Global Drug safety Specialist, mAbxience

Establishing PV quality management systems
Linda Helmfors

Linda Helmfors, QPPV & Head of Pharmacovigilance, Bluefish Pharmaceuticals Group

From local company to global player: Establishing a global PV system for highly specialized companies
Silvia Stoetter

Silvia Stoetter, Global PV Manager, Allergy Therapeutics

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

Thomas Verstraeten, Managing director, P-95

Risk minimization challenges and patient centricity
John Solomon

John Solomon, Head of Pharmacovigilance, Sanofi

Structured Benefit-Risk Assessments in the regulatory context
Bettina Doepner

Bettina Doepner, Director, Global Lead Regulatory Intelligence & Policy, Global Regulatory Affairs, CSL Behring

12:20

Networking lunch

SAFETY IN MEDICAL DEVICES

VACCINE SAFETY

REGULATION

REAL WORLD EVIDENCE IN PV

13:45

TBC

13:45

Real World Evidence (RWE) to support safety evaluation of vaccines

  • Brief overview of the global RWE landscape applying to vaccines & why vaccines are different when it comes to RWE generation
  • Recent experience with post-marketing safety evaluation of vaccines: challenges, opportunities and successes using selected examples
  • Future perspectives
13:45

Partner presentation

14:05

Regulatory requirements for influenza vaccines: vaccine effectiveness

Mendel Haag, Head Of Epidemiology, Seqirus
14:05

RWE: Predictive Analytics to Impact Patient Safety

  • The use of new analytical tools applied to “big data” and gather real-time healthcare data are on the increase in the healthcare environment and have the potential to be of great value to make more informed and reliable strategic decisions earlier when it comes to protect patient safety.
  • Real-world evidence (RWE) offers great scientific and patient benefit as well as shortening phase III to accelerate the approval procedures.
  • This is mirrored by the need for pharmaceutical and biotech companies to quickly adapt their pharmacovigilance departments into cross-functional teams to confirm the expected benefit and value, often derived largely from controlled clinical studies.
14:25

PV challenges for developing vaccines for rare diseases

  • Considerations about target populations, healthy vs. ill subjects
  • Benefit-risk assessment in low-incidence diseases
  • Ethical aspects for vaccine trials in special populations, such as paediatrics and elderly subjects
14:45

Afternoon refreshments

SIGNAL DETECTION & MANAGEMENT

DRUG SAFETY IN BIOSIMILARS & BIOLOGICS

CASE PROCESSING

PV IN EMERGING MARKETS

15:15

Chair’s remarks

Andrew Rut, CEO and Founder, MyMeds&Me
15:20

Drug safety in children

  • Specificities to take into account when performing signal detection in children
  • Importance of data entry on the results of signal detection
  • Importance of the disease
15:20

Evaluating the clinical safety of a biosimilar: totality different and/or exactly the same?

  • The “Totality of evidence”: integrating evidence across domains
  • A Bayesian perspective on the clinical safety of candidate biosimilars
  • Reflecting on residual uncertainty: the tension between a medico-scientific and a legal perspective
15:40

Partner presentation

Close of conference

last published: 14/Aug/18 08:35 GMT