8th Annual Risk Management and Pharmacovigilance Summit

5 - 6 May 2021 | ONLINE

PAST SPEAKERS

SEE THE PREVIOUS SPEAKERS & CASE STUDIES

Dr. Dimitris ZAMPATIS

Scientific Director, Safety Strategy Lead

Karsten
LOLLIKE

Corporate VP and QPPV

Pavel
GARKAVIY

Medical Director CVRM Early Clinical Development TMU

Minhaj OBEDIULLAH

Head Compliance & Risk Management

Gennaro PAGANO

Expert Medical Director & Group Leader in Early Development

CONFERENCE TOPICS 2021

LOOK AT THE TOPICS THAT WERE DISCUSSED

  • Global ongoing challenges in PV
  • What are the safety standards for pharmaceutical products?
  • Maintaining compliance in the global pharmacovigilance landscape
  • Impact of COVID-19 pandemic on pharmacovigilance
  • EU guidance on management of safety data
  • The role of signal management in the product life cycle
  • The impact of new technology on PV profession
  • Benefits and risks of using artificial intelligence in drug safety monitoring
  • EudraVigilance and new upcoming pharmacovigilance legislation processes

Designed for

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

  • Pharmacovigilance
  • Pharmacovigilance Excellence
  • Risk Management
  • Signal Detection
  • Data Collection
  • EudraVigilance
  • Patient Safety
  • Drug Safety
  • Quality Assurance
  • PV Monitoring
  • Reporting and Data Collection
  • Compliance
  • Inspections
  • Management Safety Data
  • Digital Therapeutics

Dr. Dimitris ZAMPATIS

Scientific Director, Safety Strategy Lead

CASE STUDY / DAY 1

Signal Management in Pharmacovigilance – What Is New?

During this presentation participants will have the opportunity to get an insight on the current signal detection and management guidelines and tools. What are the authorities’ expectations and findings in the signal management area? During the signal management session, pragmatic approaches, real life examples, lessons learned, as well as processes for signal management and eRMR assessment will be discussed.

  • Routine signal detection methods in EudraVigilance
  • Ongoing monitoring activities for signal detection
  • Enhanced quantitative signal detection methods (data mining)
  • Qualitative vs. quantitative assessment of ICSRs
CASE STUDY / DAY 1

Learnings from PV Inspections

PV inspections are an important process for the authorities to secure PV organisations live up to the legislation, and for PV organisations to secure they have created a QMS at the right level. The presentation will go through best practice for how to prepare and conduct an inspection, including virtual presentations. The presentation will also give examples of recent focus areas for the European authorities.

  • PV inspections overall, including inspection set-up
  • DKMA inspection on behalf of EMA
  • Local PV inspection
  • Virtual inspections
  • Summary and conclusions

Karsten LOLLIKE

Corporate VP and QPPV

Pavel GARKAVIY

Medical Director CVRM Early Clinical Development TMU

CASE STUDY / DAY 2

Current Issues in Clinical Trial Safety

Clinical trials are a dynamic, changing, challenging and demanding environment. It provides with ongoing accumulation of feasibility, clinical and safety data. Blinding non-real time, third party data review with delayed medical monitoring assessment poses certain risks to potential signals detection, risk management, protocol amendments and eventually patient’s well-being and scientific data integrity. An issue that requires practical and pragmatic solutions.

  • Medical monitoring, real-time, delayed, periodic
  • Accumulating safety data, periodic reporting
  • Educating your investigators, your colleagues and yourself
  • Patients first, do the right thing, collect additional information
  • Signals and trends, follow the science, know your pre-clinical and early clinical data
CASE STUDY / DAY 2

Leveraging Data Analytics for Operational Excellence

Modern day vigilance systems tend to generate enormous amounts of data from many different sources. These fragmented data sources create difficulties in identifying trends across complex processes and systems. Connecting these multiple data sources to a single platform supports a centralized tool facilitating continuous process improvements and early detection of operational risks

Minhaj OBEDIULLAH

Head Compliance & Risk Management

SPONSORS

Good event where pharma companies can exchange experience. I got a very good overview about the hot topics in PV and current needs and developments.

Head Clinical Drug Safety at Vifor Pharma

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