6th Annual

Global Pharmacovigilance

and Risk Management


7th - 9th June 2022, Amsterdam

(Time Zone: CEST)

In-Person & Online

Case Studies

Some Of Our Keynote Speakers

“get inspired from the world’s leading experts”


Jens-Ulrich Stegmann

SVP, Head Clinical Safety and Pharmacovigilance GSK | EU-QPPV for GSK and ViiV Healthcare


Mircea CIUCA

Global Therapeutic Area Head - Global Clinical Safety and Pharmacovigilance

Raj Bhogal

Senior Director, R&D Audits & Inspections at Jazz Pharmaceuticals


Vice President, EU QPPV


Magnus Nord

Vice President, Global Patient Safety BioPharma at AstraZeneca; Professor.

Fabio De Gregorio

Vice President, Head of Drug Safety Europe, UK QPPV at Shionogi Europe

Klaudija Marijanovic Barac

Sr. Director, EU&UK QPPV deputy & Head PSUR and RMP Unit; Medicines for Europe - PV WG Co-Chair


Patrick M. Caubel

Chief Safety Officer

Some of their Case Studies

Case Study

Day 1

Infusing intelligent automation into Pharmacovigilance and Risk Management processes

  • Case studies of integrating Machine Learning and Automation into safety processes
  • Challenges and concepts to overcome them
  • Next steps towards orchestration

This presentation focuses on how to spot good use cases and turn them into successful proof of concepts and pilots. We will draw from several examples from different areas of safety using different technologies, namely convolutional neural network in case management, knowledge graph in signal evaluation and natural language processing in additional risk minimization. We will share our approach to achieve intelligent automation, how we overcame the many obstacles so far and which challenges we anticipate to encounter next.

Case Study

Day 1

Remote audits and inspections:
  • What has changed in comparison to pre-pandemic period?
  • Remote vs. onsite – what are the key differences?
  • How to prepare for a remote audit/inspection?
  • What does the future hold?

Case Study

Day 2

PASS evaluating Risk Minimization Measures: A European Perspective during/post the COVID-19 Pandemic

  • The presentation will provide an introduction to the purpose and value of evaluating risk minimization measures (RMMs) in line with European regulatory guidance. Examples of how RMMs evaluations are conducted in different therapeutic area will be presented.

  • The challenges posed by the pandemic early in 2020 to the entire healthcare delivery system, including educational interventions and ongoing PASS, will be discussed together with regulatory measures undertaken.

  • Finally, the presentation will draft way forward to evaluate RMMs in the post pandemic era.

Event Silver Sponsors

ProPharma Group is an industry leader providing life science consulting, medical information, pharmacovigilance, and regulatory affairs services to the pharmaceutical, biotechnology, and medical device industries.

We enable clients to deliver their products to patients in the most safe, compliant, and timely manner possible. Backed by years of experience, our highly trained team understands the needs companies have in this heavily regulated environment. ProPharma Group’s experts custom tailor solutions for each of our clients based upon their unique needs and goals.

By creating an integrated compliance solution, ProPharma Group is your global, single source for the insights and services needed to maintain the highest level of value and patient safety throughout the product lifecycle. We are headquartered in Overland Park, Kansas with offices across the country, and around the world.

MS Pharm is a company established by experienced experts with a view to setting the standards and providing the highest level of services.  It enjoys extensive experience in pharmacovigilance and its own team of experienced reviewers and experts (physicians, pharmacists) – many of them gained their knowledge working for many years in global pharmaceutical companies. The MS Pharm experience comes also from a series of audits and inspections carried out in the company.

MS Pharm domain is the monitoring of medical literature in terms of pharmacovigilance and local pharmacovigilance support in Europe, CIS, Middle and Far East countries (eg. Vietnam) based on knowledge of local national pharmacovigilance requirements in individual countries – we work with local experts in pharmacovigilance.

The top quality of our processes, quality management system and their compliance with GVP requirements are confirmed by the Certificate of compliance obtained for the second time in 2020 after the independent audit.

We are focused on local medical literature monitoring and local pharmacovigilance services across the Europe and CIS countries.

Our advantages are:

  • extensive experience (collectively, over 300 years of experience in pharmacovigilance)
  • own team of local reviewers and experts (physicians, pharmacists)
  • knowledge of local pharmacovigilance requirements
  • regular quality control of all processes
  • own validated tools that allow to automate the processes

Our goal is to become a leader in medical literature monitoring and set standards in this area. We aim to be a partner you can rely on.

DrugCard is a cost-effective full-regulatory compliant software designed to automate medical literature monitoring for drug safety departments.

With DrugCard, pharmacovigilance professionals can make important decisions without deep dive into a routine. As our software provides automated weekly medical literature screening, storing, and analyzing safety information following GVP requirements. So, with DrugCard, you will have no deficiency on audits and inspections.

– automated local MLM in more than 100 languages
– access journals which not included in international databases, including printed publications
– stay up to date with daily email notifications
– unbreakable IT infrastructure that is designed by industry leaders and certified by SOC type 2/3 and ISO/IEC 27001:2013
– automated reports and records about all your GVP activity

DrugCard replaces the manual reading of journals by PV specialists, reducing the dependence on human resources and the cost of drug safety activities. Typically, DrugCard implementation takes only one week, so you could start saving money on PV activities instantly.


DrugCrads organizing giveaway of the famous Ukrainian postal stamp “Russian warship go… ” at the event to support the Ukrainian people.