8th Annual Risk Management and Pharmacovigilance Summit

4 – 6 May 2021 | Vienna

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!

Hottest topics will be discussed this annual

  • 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

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 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

Pavel GARKAVIY

Medical Director CVRM Early Clinical Development TMU

CASE STUDY DAY 1

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

Jeremie Dedessus LE MOUTIER

Global Head of PV Excellence

CASE STUDY DAY 1

Strategic PV Process Management: Beyond GVP

Classical approach to process management in global PV systems are currently facing multiple challenges from increased volume and diversified source of data, data integrity, diversified and scrutinised regulatory landscape, pressure on workforce. We will explore some integrated approaches (process ownership, innovation, quality by design) that PV professionals could use to overcome those challenges as well as risk and opportunities.

• End-to-end process management
• Quality by design and data integrity
• Innovation: Data with untapped potential
• Risk and opportunities

Gennaro PAGANO

Expert Medical Director & Group Leader in Early Development

CASE STUDY DAY 2

COVID-19 Pandemic Disruptions of Clinical Trials Highlight the Need for a Digital Transformation and the Challenge for Pharmacovigilance: The Case of Parkinson's Disease

The COVID-19 pandemic has disrupted clinical trials worldwide, with long-lasting effects on medical science. The COVID-19 pandemic has created massive disruptions to clinical trial research across the world. As in other aspects of life, the virus has severely affected the ability to conduct trials in safe and effective ways. This is especially true when considering that trials often deal with vulnerable populations who are most at risk from exposure to COVID-19, such as people with Parkinson's disease. Thousands of trials have been suspended or stopped because of the difficulties in continuing under lockdown conditions, even as those restrictions have begun to ease in parts of the world. Both of those aspects—the disruption and the fast, effective readjustment to address a new challenge—ensure that the effects of the COVID-19 pandemic will be felt in clinical trials research long after the initial effects have faded. To solve this issue, a revolutionary digital transformation approach to trial conduct is deemed necessary but this will create new challenge in pharmacovigilance.

• Highlights of COVID-19 pandemic disruption of clinical trials
• Digital transformation as a solution: The case of Parkinson’s' disease
• Challenges for pharmacovigilance

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

We offer to world’s leading companies at our summit

Case Studies

Experience leaders will provide you with lessons learned.

Networking

The chance for market-leading business knowledge networking.

Discussions

All attendees will have a great opportunity to discuss a selection of topics in small groups with their peers.

New Ideas

We are partnering with experienced professionals to provide creative ideas, inspiration, and guidance.

Allan Lloyds Summit mission is to exceed expectations

We are committed to achieving new standards of excellence by providing conference formats that encourages interaction, networking and high class knowledge sharing. With experts, well-supported staff, motivated to deliver quality, Allan Lloyds vision is to be recognized as the global leader in providing high quality business conferences.

What we offer to world’s leading companies

  • Experience-based case studies
  • Round table discussions
  • Impeccable networking opportunities
  • Limited number of seats in the audience ensuring friendly atmosphere
  • No media or press presence

Few photos from our summits

Event programme

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  • What keynote speakers will be taking part in the exclusive speaking panel
  • What Case Studies will be discussed by our senior corporate speakers
  • The minute by minute breakdown of the conference