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6TH ANNUAL RISK MANAGEMENT AND PHARMACOVIGILANCE SUMMIT

17 - 19 SEPTEMBER 2019, VIENNA
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PAST SPEAKERS

SEE THE PREVIOUS SPEAKERS & CASE STUDIES

Nicola
GROTH

Head Safety Evaluation & Risk Management Italy

Sally
LEE

Senior Director, Epidemiology, Global Drug Safety and Risk Management

Richard
HUGHES

Safety Science Senior Medical Director

Susan
BHATTI

Director EU Global Regulatory and Scientific Policy

Andreas
OSANGER

Head of Clinical Drug Safety

Bolatito
ABATAN

Associate Director, Growth & Emerging Markets, PV Affiliate Relations

CONFERENCE TOPICS 2019

LOOK AT THE TOPICS THAT WERE DISCUSSED

  • Use of Real World Data in Supporting Pharmacovigilance
  • Pharmacovigilance in the Emerging Markets
  • Strategic Partnerships in PV
  • Strategic Drug Safety & PhV: Learnings and Practical Considerations
  • QPPV Regulations in Non-EU Countries – Implications for Multi-/National MAH
  • From Clinical Monitoring to Signal Detection in Clinical Development
  • The Role of Quality Assurance in PV
  • Patient Involvement in Clinical Development of Medicines
  • Integrating Safety Evidence

DESIGNED FOR

Who Should Attend – Members of board, C-level, Senior/Global Vice Presidents, Directors, Heads of departments from pharmaceutical industry involved in:

  • Pharmacovigilance
  • Drug Safety
  • Safety & Risk Management
  • Signal Detection
  • Benefit-Risk Assessment
  • Safety Evaluation
  • Regulatory Affairs, Pharmacovigilance
  • PV Governance
  • Safety Surveillance
  • Pharmacovigilance Operations
  • PV Inspection and Audit Readiness
  • Patient Support Programs
  • Market Research Programs
  • Clinical Safety
  • Medical Safety
  • Medical Information
  • Pharmacoepidemiology
  • Quality Assurance, Pharmacovigilance

CASE STUDIES

PAST CASE STUDIES INCLUDE

CASE STUDY / DAY 1

Use of Real World Data in Supporting Pharmacovigilance

Real world data/evidence has become a hot topic in the pharmaceutical industry in the past decade. This presentation will focus on how RWD/RWE can be applied within pharmacovigilance field in order to assess safety profile of treatment in the real world setting.

  • Potential sources of RWD for pharmacovigilance
  • Types of studies using RWD to support PV
  • Examples of studies using RWD in PV
  • Future of RWD in PV

Sally
LEE

Senior Director, Epidemiology, Global Drug Safety and Risk Management

Andreas
Osanger

Head of Clinical Drug Safety

CASE STUDY / DAY 1

One Step Ahead: From Medical Monitoring to Signal Detection in Clinical Development

Medical monitoring is the industry standard when conducting Phase 1-3 clinical trials. However, are we sure that we do not miss any safety signals? Analysing drug safety data – possibly in real time – in an aggregated manner may support signal detection activities in our clinical development programs. And can we learn from the well-established post-marketing signal detection management?

  • Signal detection and management in clinical studies
  • Pre-marketing safety surveillance
  • Advanced medical monitoring
  • Clinical drug safety

CASE STUDY / DAY 2

Communicating Safety to Patients and Clinicians

The role of pharma in communicating safety information has traditionally revolved solely around regulatory requirements. This talk will explore the demand from patients and clinicians for a broader and more transparent communication of safety data from not only clinical trials, but also the post-marketing setting.

  • The history of safety
  • Safety in the digital world
  • Two views of safety information communication
  • Case study – Ocrevus in Multiple Sclerosis

Richard
HUGHES

Safety Science Senior Medical Director

Bolatito
ABATAN

Associate Director, Growth & Emerging Markets, PV Affiliate Relations

CASE STUDY / DAY 2

Pharmacovigilance in the Emerging Markets

The presentation will cover emerging markets regulations and industry response, PV model of Takeda and strategies such as Access to Medicine.

  • Pharma in Emerging Markets
  • PV in the Emerging Markets
  • Regulatory Landscape
  • Harmonization efforts

Workshop A
17 September 2019 I 15.00 – 16.00

Pharmacovigilance Inspection and Audit Readiness

  • What are the most common failures found by the inspection?
  • Sufficient oversight of all third parties as a crucial step to pass the inspection
  • CAPA Management – Resolving inspection findings
  • Communication with the inspector
  • Inspection preparation and documentation

Workshop B
17 September
2019 I 16.00 – 17.00

Reporting and Data Collection in PV

  • Spontaneous reporting systems as the cornerstone of pharmacovigilance
  • The value of patient reporting to the pharmacovigilance system
  • How to stimulate reporting so it becomes an accepted and understood routine?
  • Leveraging data from multiple data sources including: Google searches, Twitter microblogs, nearly real-time hospital visit records, and data from a participatory surveillance system
  • What is new in the guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use?

SPONSOR 2019

A SPECIAL THANK YOU TO OUR SPONSORS

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