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2-Day Pharmacovigilance Europe Congress 2019 (London, United Kingdom - May 22-23, 2019) -

The "Pharmacovigilance Europe Congress 2019" conference has been added to's offering.

Pharmacovigilance Europe 2019 Congress will give its participants an opportunity and a platform to share experiences with the likeminded individuals in the field. The conference will also provide an insight into the complexities and challenges impacting public safety and risk management, focusing mainly on drugs, biologics and medical devices and the future of PV in the globalization era.

The conference will bring together industry experts and regulators to discuss the new updates in EU legislation, operational challenges of implication of these changes, experience of implementing global risk management plans, the best and effective way forward, impact of IT and social media on PV and harmonization of different regulatory bodies.

Key Themes

  • Explore the impact of PV legislation changes and updates on industries and the best practices
  • Assuring Compliance and its monitoring
  • Preparing for PV audit and inspections and the role of QPPV
  • Risk management plans, strategies and new risk- benefit analysis tools to improve REMS reporting
  • Implementing risk management and safety surveillance methodologies for medical devices
  • New approaches for risk minimization and communication
  • Determining steps and strategies for more transparency and involvement of patients
  • Discussing the how IT and Social media effect Pharmacovigilance and Adverse events reporting
  • Discuss and review the use of databases and emerging tools for generation and detection of safety signals
  • Importance of outsourcing and its effectiveness
  • Harmonization of regulatory framework - developed and emerging markets

Why Should You Attend

Pharma/BioTech companies are always faced with the challenge to improve quality of the safety data with the ever-increasing quantity of the data. The companies are also left with the challenge to manage the dynamic regulatory requirements. There are still many complexities that the industries and the regulatory authorities have to tackle.

With more communication and networking you can expand your knowledge on the key complications currently experienced by various industries and departments and design new strategies to overcome the same.



8.30 - 9.30

  • Registration & Refreshments

9.30 - 9.45

  • Chair Person Opening Remarks

9.45 - 10.30

  • Risk Management in PV
  • From observation to management of risks
  • Risk management in different jurisdictions
  • How effective is your risk management
  • What we can learn from other industries

10:30 - 11:00

  • Preparing and Managing Safety Data Exchange Agreements
  • Legal basis for Safety Data Exchange Agreements
  • Importance of SDEA
  • Types of Safety Data Exchange Agreements
  • How to monitor the compliance of SDEAs
  • SDEAs and Inspections
  • Smart Tools for monitoring and oversight of SDEAs

11:00 - 11:30

  • Morning Coffee/Tea & Networking

11:30 - 12:00

  • PV Systems Inspections
  • PV System Element Ownership
  • Types of PV System Inspections
  • PV System Inspection Support
  • Inspection Management
  • Inspection Readiness
  • PV System Legislation Updates
  • Regulatory Agency Trends
  • Consequences of Poor Inspections

12:00 - 12:30

  • Role of Artificial Intelligence in PV
  • Are stakeholders and PV systems ready to embrace AI?
  • Challenges around use of AI in PV
  • Role of subject matter expert in presence of AI

12:30 - 13:45

  • Networking luncheon

13:45 - 14:15

  • Utilising Digital Patient Experience to improve Products and Communication
  • The increasing use of online sources for health information
  • Customer Voice Monitoring: A methodology to receive meaningful customer insights from online sources
  • Use case: Monitoring of patient experience with OTC drugs

14:15 - 14:45

  • The new E2B R3: A reflection on experience to date
  • Some of the challenges faced and considerations for implementation
  • How does R3 compare with R2 and what are the implications during transition
  • Sharing our practical experience and the potential impact on workflow

14:45 - 15:15

  • Afternoon Tea/Coffee

15:15 - 15:45

  • Role of PV in Biologics
  • Overview of biological medicines
  • PV aspects specific to biological medicines
  • Product traceability

15:45 - 16:45

  • Panel Discussion
  • PRAC Strategies to measure the Impact Factor of Pharmacovigilance

16:45 - 17:00

  • Chairperson's closing remarks

17:00 - 18:00

  • Networking Drinks Reception


8.30 - 9.30

  • Registration & Refreshment

9.30 - 9.45

  • Chairperson's opening remarks

9.45 - 10.30

  • MAHs access to and obilgations in Eudravigilance, First Experiences
  • GVP Module lX updates
  • Experiences with contact with EMA about this subject
  • Organisational changes to comply (the 2017 organisation in Astellas, the changes because of the Module update (staff, procedures))
  • First experiences (products, results of Eudravigilance Signal Detection runs')
  • Hopes and predictions for the period after this pilot (until Feb 2019)

10:30 - 11:00

  • GVP IX - updates related to signal management

11:00 - 11:30

  • Morning Coffee/Tea & Networking

11:30 - 12:00

  • PV inspections - where are we now - GXP inspection types and
  • pharmacovigilance - Different inspectorates methods and approaches -
  • Where to next?... status quo or time for change?

12:00 - 12:30

  • Do we correctly communicate the risks of medicines and vaccines to the general public?
  • Treatment efficacy does not only depend on the active ingredient pharmacology and on the medicinal product pharmacodynamics, but it is also influenced by patients' expectations
  • Pharmacovigilance focuses on making patients' aware of all adverse reactions and on communicating risk minimization measures, not so much on the psychological reaction the information has on the patients
  • Communications on the safety of a medicinal product should be tailored and monitored having in mind what could be the risks of patients' overreaction to this information

12:30 - 13:00

  • Pharmacovigilance Market Overview:
  • Trends in outsourcing
  • Market segments
  • Outsourcing models

13:00 - 14:00

  • Networking luncheon

14:00 - 14:30

  • All Safety Variations Sources: Keeping Generic Product Information up to date
  • Legal obligation - tracking scientific knowledge
  • PRAC signal recommendations
  • PSUR and PSUSA recommendations
  • Referrals - long story become short deadline

14:30 - 15:00

  • First Three Months using EVDAS - Practical Aspects

15:00 - 15:30

  • Afternoon Tea/Coffee

15:30 - 16:00

  • Brexit and the Impact on Pharmacovigilance

16:00 - 16:45

  • Panel Discussion & Speak Out Session - HOT Topics
  • Patient Support Programme
  • Medication Errors
  • Off Label Usage

16:45 - 17:00

  • Chair person's closing remarks and end of conference

For more information about this conference visit

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Last Updated: 13-Nov-2018