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Overview

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DIA has a long history of working closely with Industry and Regulators to bring topics and speakers together with broad audiences in order to create stimulating and relevant discussions.

Join this Workshop to discuss the current PV landscape and partake in lively and constructive dialogue that is designed to expand your knowledge and enhance your practices in the following areas:

  1. Data Privacy in Pharmacovigilance
  2. Signaling and access policy to the EV database
  3. Safety reporting: concerns with use of new RSI guidance and issues that remain outstanding
  4. EU Clinical Trial Regulation: Implementation and Readiness
  5. Risk-Management Plan

The conference format is designed to stimulate dialogue and generate solutions through a series of interactive sessions and workshops. An informal setting allows for in-depth discussion in smaller groups.

Featured topics

  • GDPR in Pharmacovigilance: Impact and Management of Data
  • Signalling and emerging safety issues
  • Inspections: Hot Topics
  • Safety Agreements
  • EV Requirements: Where are we now?
  • Implementation of EU Clinical Trial Regulation
  • Risk Management Plan

Who should attend?

Established professionals who are seeking to increase their network of like-minded colleagues; share their thoughts and practices with others; learn the most current regulatory views and gain practical knowledge in key areas in pharmacovigilance, including:

  • Signal management
  • Data Privacy
  • Risk Management Planning
  • PSMF maintenance
  • Clinical Trials

Professionals involved in:

  • Drug Safety/Pharmacovigilance
  • Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
  • Benefit-risk assessment and communication
  • Medical Product Safety Assessment
  • Regulatory Affairs
  • Clinical Trials
  • Pharmaceuticals, biologics, combination products, devices
  • Clinical Research and Clinical Research Organizations
  • Health Outcomes
  • Academic Research Centers
  • Regulatory Agencies 

Learning objectives

  • Seek direct answers to the business challenges you are facing every day
  • Understand how other organisations are managing through the shift of sharing all information to sharing relevant information
  • Ensure that your pharmacovigilance work matches up with inspector expectations, and delivers efficient outcomes for patients.

Program Committee

  • Gaby L. Danan, MD, PhD
    Gaby L. Danan, MD, PhD Pharmacovigilance Expert
    GLD, France
  • Margaret Anne Walters
    Margaret Anne Walters Deputy EU Qualified Person for Pharmacovigilance
    Merck, Sharp & Dohme Ltd, United Kingdom
  • Maria  Wishart
    Maria Wishart Deputy EU QPPV
    Astrazeneca, United Kingdom
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