8th Annual Risk Management and Pharmacovigilance Summit


In today’s fast changing and unforeseeable times, pharmaceutical companies need to follow a wide range of processes and stick to the majority of regulations, in order to ensure their pharmacovigilance is up to standards. But how to be in charge of the key component of effective drug regulation systems? The answer is quite easy: follow the worldwide master key for drug safety monitoring, well known as pharmacovigilance. It is an important and integral part of clinical research and these days it is growing in many countries. Pharmaceutical companies require a team of professionals and pharma experts who are able to carry on this constant quality check journey for their drugs. How is it actually practiced today? Did the global pandemic change the face of PV evolution? How to prevent all undue physical, mental and financial suffering by patients? Let us see what is beyond the “unknown” about the safety of the new drugs.

8th Annual Risk Management and Pharmacovigilance Summit has been designed to cover all the current topics and challenges that are important to explore and find the answers on how to assess long-term and short-term adverse effects of a drug, what are the most common failures found by the inspections, what are the new PV legislations and regulations they need to be prepared for, how to enhance quantitative signal detection, what are the main risk minimisation tools applied in the biggest European pharma companies, what is the impact of technologies on the pharmacovigilance profession and many others. At our risk management and pharmacovigilance event you will hear real-life case studies and meet representatives of leading pharma companies that have managed to provide the best safety measures to their patients.

This interactive pharma conference will provide you with lessons learned and valuable tips shared by top players of the industry. You will also benefit from remarkable networking opportunities due to limited seats of this business event. It is the right place for sharing ideas, getting insights and inspiration, learning from experienced leaders and establishing important business contacts!

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Key speakers

Amgad SHEBL

Amgad SHEBL

Director, Clinical Safety Physician
Gennaro PAGANO

Gennaro PAGANO

Expert Medical Director & Group Leader in Early Development
Jeremie Dedessus LE MOUTIER

Jeremie Dedessus LE MOUTIER

Global Head of PV Excellence
Pavel GARKAVIY

Pavel GARKAVIY

Medical Director CVRM Early Clinical Development TMU
Karsten LOLLIKE

Karsten LOLLIKE

Corporate Vice President and QPPV
Dr. Dimitris ZAMPATIS

Dr. Dimitris ZAMPATIS

Scientific Director, Safety Strategy Lead


Key topics

  • 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



Who Should Attend

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
  • Clinical Safety