SPEAKERS

SAMPLE OF KEYNOTE SPEAKERS AND THEIR CASE STUDIES

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

SUMMIT WILL HOST SPEAKERS FROM THE WORLD’S LEADING COMPANIES

Dr. Dimitris ZAMPATIS

Scientific Director, Safety Strategy Lead

CASE STUDY DAY 2

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

Karsten LOLLIKE

Corporate VP and QPPV

CASE STUDY DAY 2

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

Pavel GARKAVIY

Medical Director CVRM Early Clinical Development TMU

CASE STUDY DAY 1

Co-Creating Win-Win Success

The success of clinical trials begins with understanding what 'great' looks like from a participant’s perspective, in addition to a regulatory perspective. The two are now united in advice from the EMA and FDA both, and as such engaging disease experience experts (aka 'patients') from the get-go is a must.

• Co-creating R&D: An example on a partnership for change
• How related engagement may look like
• How win-win outcome may look like

Minhaj OBEDIULLAH

Head Compliance & Risk Management

CASE STUDY DAY 1

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.

Gennaro PAGANO

Expert Medical Director & Group Leader in Early Development

CASE STUDY DAY 1

Challenges and Uncertainties from Patient Perspectives

In this presentation the speaker will focus on the topics connected with
his Editorial and some others which focus on patient perspective in relation
to patient enrolment and retention in clinical studies.

• COVID-19 vaccine, patient safety
• Challenges and uncertainties
• Patient recruitment and retention in clinical studies

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

Very relevant topics from everyday practicalities to more visionary. Experienced & knowledgeable speakers. I really liked the quality of topics and their usefulness.

Senior Director Safety Risk Lead at Pfizer

Event programme

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