7TH ANNUAL RISK MANAGEMENT AND PHARMACOVIGILANCE SUMMIT

10 – 11 SEPTEMBER 2020 | VIENNA

SUMMIT IS OVER

STAY UPDATED FOR 2021 EDITION
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PAST SPEAKERS

SEE THE PREVIOUS SPEAKERS & CASE STUDIES

Gabrielle
AMSELEM

Deputy EUQPPV - PSMF Manager

Begum
BENLI PEKER

Associate Director, International Operations & PV Intelligence

G. Scott
CHANDLER

Global Head, Personalised Health Care (PHC) Safety

Mate
BALAZS

Country Head- Patient Safety

Karsten
LOLLIKE

Corporate Vice President and QPPV

Tjark
REBLIN

Global Head Drug Safety and Risk Management

CONFERENCE TOPICS 2020

LOOK AT THE TOPICS THAT WERE DISCUSSED

  • Patient-centric approaches to proactive safety and risk management
  • Counterfeit of pharmaceutical products
  • Inspection readiness – How to get ready for an inspection?
  • Safety evaluation and understanding of the safety profile of a medicine
  • Is PIL the best way to communicate risk to patients?
  • Increasing QPPV requirements – Maintenance and expansion of a Pharmacovigilance System Master File (PSMF)
  • The value of direct patient reporting in pharmacovigilance and the inclusion of patients in the decision-making process & Health Literacy
STAY UPDATED FOR 2021 EDITION

DESIGNED FOR

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 Programmes
  • Market Research Programmes
  • Clinical Safety
  • Medical Safety
  • Medical Information
  • Pharmacoepidemiology
  • Quality Assurance, Pharmacovigilance

CASE STUDIES

PAST CASE STUDIES INCLUDE

CASE STUDY / DAY 1

Counterfeit of Pharmaceutical Products – What Are the Risks and How to Mitigate Them?

Counterfeiting of pharmaceutical products is a global health issue, that is a growing concern. According to PSI (Pharmaceutical Security Institute), in some countries more than 25% of the medicines sold are counterfeit and with increasing consumer purchasing of medicines online, counterfeiting can go up in all countries. The fight against counterfeiting is multidisciplinary and collaboration with health authorities and police is vital.

  • Counterfeiting – A global health issue
  • Counterfeiting – Are pharmaceutical companies responsible?
  • How to monitor for counterfeited products?
  • How to reduce the risk of counterfeiting?

Karsten
LOLLIKE

Corporate Vice President and QPPV

G. Scott
CHANDLER

Global Head, Personalised Health Care (PHC) Safety

CASE STUDY / DAY 1

Patient-Centric Approaches to Proactive Safety and Risk Management

Proactive safety and risk management requires a patient-centric approach in order to understand the potential drivers of toxicity and how to best mitigate them. Evolving capabilities in generic profiling, advanced analytics and increased understanding of disease biology provide new opportunities to characterise risk and intervene more specifically. The presentation will highlight some recent advances and novel approaches for evaluating toxicity and disease biology in order to demonstrate how proactive and patient-centric approaches can be applied to pharmacovigilance.

  • Proactive, patient-centric, and pharmacogenomics approaches to safety and risk management are key components of personalised healthcare
  • Pharmacogenomics are also a regulatory imperative and patient-centricity is expected by health authorities
  • Evolving capabilities in genetic profiling, advanced analytics and disease modelling provide new opportunities to predict and mitigate toxicity to better optimise the benefit/risk balance for individual patients

CASE STUDY / DAY 2

Inspection Readiness – How to Ensure It

This presentation will provide a brief overview of PV inspection topics and common questions, and also inspection readiness activities and examples to ensure being always ready for being inspected.

  • How to get ready for an inspection?
  • What are the questions commonly asked during an inspection?
  • How to identify issues before the inspection and avoid findings?

Begum
BENLI PEKER

Associate Director, International Operations & PV Intelligence

Tjark
REBLIN

Global Head Drug Safety and Risk Management

CASE STUDY / DAY 2

A Framework for Safety Evaluation

Evaluation of the safety profile of medicines is moving from a more reactive approach to a more proactive endeavour with cross-functional teams strategically evolving their understanding of the safety profile of a medicine. This is done by anticipating the benefit-risk profile and its related risk management implications from the start of development. The approach involves addressing sets of questions targeted to further exploring the safety profile of an asset based on its development stage and maturity. The approach involves a collaborative multidisciplinary view via a diverse safety management teams representing relevant cross-functional partners, starts early in the development of a new medicine, and continues into the post-marketing setting. It serves as the basis for any risk management and mitigation activities throughout the lifecycle of a medicine.

STAY UPDATED FOR THE 2021 EDITION

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