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12th Annual Risk
Management and
Pharmacovigilance
Summit
21 - 22 May, 2025
Berlin
Past Speakers
STAY TUNED! THE AGENDA WILL BE ANNOUNCED SOON
CASE STUDY
Assessment of Benefit-Risk During Clinical Development
- 01The Regulator perspective on benefit-risk assessment during drug development
- 02Use of the structured benefit-risk assessment framework during drug development to inform milestone decisions
- 03Structured benefit-risk assessment during drug development — an evolving and iterative process to understand benefit-risk in a patient-centric manner
CASE STUDY
Unravelling the Complexity of Signal Detection and Risk Assessments on the Oncology Therapeutic Area
This presentation aims to emphasise the challenges of signal detection and risk assessments within the Oncology Therapeutic Area. In addition, it provides some useful insights on how to address some of the main challenges in this landscape.
- 01Main differences and challenges of Oncology vs other Therapeutical Areas
- 02How to address the main challenges in signal detection
- 03Risk Assessment in Combination Therapies
CASE STUDY
The Pitfalls of the EU PSMF
- 01How insufficient attention to detail leads to errors, omissions, or inaccuracies in the PSMF?
- 02Cross-functional collaboration, a key aspect often forgotten
- 03Failure to update the PSMF, now what?
CASE STUDY
Future of Pharmacovigilance Systems — Lessons Learned From COVID-19 Pandemic
COVID-19 pandemic started in late 2019 in China, expanding worldwide rapidly in early 2020. It resulted in 7 mln deaths. It became a novel challenge to the pharmacovigilance system worldwide for the whole pharma industry, particularly those parties that introduced vaccines against COVID-19. The development of vaccines and the unprecedented volume of ISRs reported in a short period of time after mass vaccination programmes started resulted in various types of challenges that required new ways of managing data, risk, reporting, controls and application of new technologies. The pandemic provided lessons learned that impacted the future of effective pharmacovigilance systems.
- 01Pharmacovigilance conditions evolution during the COVID-19 pandemic
- 02EU countries’ role in generating vaccine ICSRs volumes
- 03Increasing role of patients/customers engagement in PV system and case volume
- 04Regulatory framework landscape changes and increase of national requirements
- 05Social media as the preferred communication channel for safety/efficacy topics and its implication for PV system
- 06Novel technologies application across all PV activities
CASE STUDY
Innovations in Global Drug Safety: A Comprehensive Approach to Risk Management and Pharmacovigilance
- 01Balancing time, cost and quality to maximise overall outcomes
- 02Driving process optimisation in order to accelerate to value!
- 03Harnessing the team to achieve excellence
CASE STUDY
Assessment of Benefit-Risk During Clinical Development
- 01The Regulator perspective on benefit-risk assessment during drug development
- 02Use of the structured benefit-risk assessment framework during drug development to inform milestone decisions
- 03Structured benefit-risk assessment during drug development — an evolving and iterative process to understand benefit-risk in a patient-centric manner
CASE STUDY
Unravelling the Complexity of Signal Detection and Risk Assessments on the Oncology Therapeutic Area
This presentation aims to emphasise the challenges of signal detection and risk assessments within the Oncology Therapeutic Area. In addition, it provides some useful insights on how to address some of the main challenges in this landscape.
- 01Main differences and challenges of Oncology vs other Therapeutical Areas
- 02How to address the main challenges in signal detection
- 03Risk Assessment in Combination Therapies
CASE STUDY
The Pitfalls of the EU PSMF
- 01How insufficient attention to detail leads to errors, omissions, or inaccuracies in the PSMF?
- 02Cross-functional collaboration, a key aspect often forgotten
- 03Failure to update the PSMF, now what?
CASE STUDY
Future of Pharmacovigilance Systems — Lessons Learned From COVID-19 Pandemic
COVID-19 pandemic started in late 2019 in China, expanding worldwide rapidly in early 2020. It resulted in 7 mln deaths. It became a novel challenge to the pharmacovigilance system worldwide for the whole pharma industry, particularly those parties that introduced vaccines against COVID-19. The development of vaccines and the unprecedented volume of ISRs reported in a short period of time after mass vaccination programmes started resulted in various types of challenges that required new ways of managing data, risk, reporting, controls and application of new technologies. The pandemic provided lessons learned that impacted the future of effective pharmacovigilance systems.
- 01Pharmacovigilance conditions evolution during the COVID-19 pandemic
- 02EU countries’ role in generating vaccine ICSRs volumes
- 03Increasing role of patients/customers engagement in PV system and case volume
- 04Regulatory framework landscape changes and increase of national requirements
- 05Social media as the preferred communication channel for safety/efficacy topics and its implication for PV system
- 06Novel technologies application across all PV activities
CASE STUDY
Innovations in Global Drug Safety: A Comprehensive Approach to Risk Management and Pharmacovigilance
- 01Balancing time, cost and quality to maximise overall outcomes
- 02Driving process optimisation in order to accelerate to value!
- 03Harnessing the team to achieve excellence
CASE STUDY
Assessment of Benefit-Risk During Clinical Development
- 01The Regulator perspective on benefit-risk assessment during drug development
- 02Use of the structured benefit-risk assessment framework during drug development to inform milestone decisions
- 03Structured benefit-risk assessment during drug development — an evolving and iterative process to understand benefit-risk in a patient-centric manner
CASE STUDY
Unravelling the Complexity of Signal Detection and Risk Assessments on the Oncology Therapeutic Area
This presentation aims to emphasise the challenges of signal detection and risk assessments within the Oncology Therapeutic Area. In addition, it provides some useful insights on how to address some of the main challenges in this landscape.
- 01Main differences and challenges of Oncology vs other Therapeutical Areas
- 02How to address the main challenges in signal detection
- 03Risk Assessment in Combination Therapies
CASE STUDY
The Pitfalls of the EU PSMF
- 01How insufficient attention to detail leads to errors, omissions, or inaccuracies in the PSMF?
- 02Cross-functional collaboration, a key aspect often forgotten
- 03Failure to update the PSMF, now what?
CASE STUDY
Future of Pharmacovigilance Systems — Lessons Learned From COVID-19 Pandemic
COVID-19 pandemic started in late 2019 in China, expanding worldwide rapidly in early 2020. It resulted in 7 mln deaths. It became a novel challenge to the pharmacovigilance system worldwide for the whole pharma industry, particularly those parties that introduced vaccines against COVID-19. The development of vaccines and the unprecedented volume of ISRs reported in a short period of time after mass vaccination programmes started resulted in various types of challenges that required new ways of managing data, risk, reporting, controls and application of new technologies. The pandemic provided lessons learned that impacted the future of effective pharmacovigilance systems.
- 01Pharmacovigilance conditions evolution during the COVID-19 pandemic
- 02EU countries’ role in generating vaccine ICSRs volumes
- 03Increasing role of patients/customers engagement in PV system and case volume
- 04Regulatory framework landscape changes and increase of national requirements
- 05Social media as the preferred communication channel for safety/efficacy topics and its implication for PV system
- 06Novel technologies application across all PV activities
CASE STUDY
Innovations in Global Drug Safety: A Comprehensive Approach to Risk Management and Pharmacovigilance
- 01Balancing time, cost and quality to maximise overall outcomes
- 02Driving process optimisation in order to accelerate to value!
- 03Harnessing the team to achieve excellence
Ahmed Nasr
Operations Director Egypt and Director Milk Africa & Turkey
Khaled Elsharkawy
Integrated Supply Chain Senior Director
Mueen Uddin Siddique
Senior Director – Access Network Procurement
Shannon Hore
Senior Vice President Procurement and Logistics
Sandeep Sharma
Director Group Procurement & International Markets Supply Chain
Hottest topics
LOOK AT THE MAIN TOPICS OF OUR CONFERENCE
- 01Revolutionising Pharmacovigilance with AI & Machine Learning
- 02Mastering Data Integration for Smarter Pharmacovigilance
- 03Global Pharmacovigilance Regulations
- 04Crisis Management and Risk Mitigation
- 05The Future of Data in Pharmacovigilance
Testimonials
What our users say about our conferences
Very well organized, interesting topics.
Sanofi
Pharmacovigilance Risk Management Expert
Very interesting presentations from a variety of areas in PV and RM, that sparks thoughts for the own daily work as well as good discussions during breaks.
Abbvie
Senior Scientific Director BRM
Very interesting topics, good organization of the event.
CSL Vifor
Head Global Drug Safety Hub
I really liked the event, great topics and networking opportunities. I also learned a lot about the current PV challenges in all the companies.
Novo Nordisk Pharma GmbH
Officer Product Safety
Very relevant topics from everyday practicalities to more visionary. Experienced & knowledgeable speakers. I really liked the quality of topics and their usefulness.
Pfizer
Senior Director Safety Risk Lead
Very good conference with a friendly atmosphere and a panel of very good experts. Discussions were very lively and open.
Sanofi
Head of QPPV Office
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.
Vifor Pharma
Head Clinical Drug Safety
The right amount of participants allowing for good interaction between peers. Interesting topics with studies.
Takeda
Associate Director, PV Compliance
Sponsors
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