- Safety reporting activities due to the COVID-19 pandemic: What are the pillars?
- Challenges measuring the effectiveness of risk minimisation measures
- How to design a patient centred pharmacovigilance system?
- Augmenting decision-making in PV through artificial intelligence
- What are the safety standards for pharmaceutical products?
- Automation in pharmacovigilance data processing: Do you trust artificial intelligence?
- How did the pandemic push pharmacovigilance to innovate?
- The impact of new technologies on PV system
9th Annual Risk Management and Pharmacovigilance Summit
4– 5 May 2022 | Vienna
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 would be easy, well known as a PV.
Pharmacovigilance is the beating heart of pharmaceutical production. Without it, there would be no way to assess the effectiveness of drugs in comparison to their side effects. Especially today, when the pandemic is having a profound effect on the lives of millions of people around the world and the threat of disease and increasing casualties are destabilising every single industry, it’s important to protect the patients and enable the dissemination of knowledge amongst professionals to minimise the risk of adverse events. Let us see and reveal more what is hidden beyond the “unknown” of drug safety world.
The 9th Annual Risk Management and Pharmacovigilance Summit has been designed to embrace all the current topics and challenges that are important to explore and find the answers on how to embark the patients on the pharmacovigilance ships, what are the advances in structured benefit-risk assessment, what are the effective tools in signal detections, what are types of data available for predictive approaches, how to trust Artificial Intelligence for bias-free identification of risk factors for ADRs and many more. At this 9th Annual Risk Management and Pharmacovigilance conference you will hear 16+ real-life case studies and you have a chance to meet C-level representatives of leading pharma companies that have managed to provide the best safety measures to their patients in recent years.
This interactive pharma meeting will provide you with lessons learned and valuable tips shared by top players in the field. 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 valuable for your next future business path!
Hottest topics that will be discussed this annual
SUMMIT WILL HOST SPEAKERS FROM THE WORLD’S LEADING COMPANIES
CASE STUDY DAY 2
Opportunities and Challenges Measuring the Effectiveness of Risk Minimisation Measures
The presentation will provide an introduction to the purpose and value of evaluating risk minimisation measures (RMMs) with a focus on European regulatory guidance. Examples of how RMMs evaluations are conducted in different therapeutic area will be presented. The challenges posed by the COVID-19 pandemic to the healthcare delivery systems globally, including educational interventions and ongoing PASS will be discussed together with regulatory measures undertaken.
• GVP XVI revision 3 - impact of updates on risk minimisation and effectiveness evaluation
• Measuring the impact of risk minimisation interventions: PAS studies to measure the impact of risk minimisation measures
• Future perspective: use of digital tools in the (post) pandemic era
CASE STUDY DAY 1
The Role of Pharmacogenomics in Drug Safety
Patients vary in their response to a drug and genetic factors are estimated to account for 15% -20% of these differences, but for some drugs they can account for up to 95% of inter-individual variability. Frequently, multiple genes contribute to a trait and one gene can have multiple alternative forms with the relevant protein having an activity that can range from high to low. The presentation will provide examples on how both genetic and non-genetic factors influence drug dosing and therefore need to be considered in order reduce the risk of experiencing adverse reactions.
• Pharmacogenomics is the study of the genes, their polymorphism, structure, function, transcription and translation, how they interact with each other and with the environment
• It has been suggested that one third of serious adverse reactions have a genetic variant as a contributory factor
• The metabolic pathways of a drug and its pharmacodynamics are the basis for understanding why some genetic variants require to adapt the drug dose so to minimize the risk of experiencing adverse reactions
CASE STUDY DAY 1
Advances in Structured Benefit-Risk Assessment
This presentation aims to display the recent advances in Benefit-Risk field from new regulatory guidance, changes in BR methods to illustration of growing role of patient experience data into BR evaluation.
• Recent changes in Benefit-Risk regulatory landscape
• Improved use of Patient Experience Data for Benefit-Risk evaluation
• Trends and perspectives for the future in Benefit-Risk methods
CASE STUDY DAY 1
The Importance of Embarking the Patients on the Pharmacovigilance Ship
Pharmaceutical companies have been partnering with patients and patient organisations for quite a few years now, especially in engaging them regarding various aspects of clinical trials. Some topics that needs further discussions / development are for example direct safety patient reporting (tools, capacities, education) and involvement of patients in the creation of materials dedicated to them, outside clinical trials.
• Current status patient involvement clinical trials
• Direct safety reporting – status, utilisation, benefits, comparison HCP reporting, future use
• Engaging patients in creating user-friendly, innovative patient-derected-materials
• Future considerations
CASE STUDY DAY 2
Predictive Pharmacovigilance
Pharmacovigilance has moved from reactively reporting safety information to planning risk management activities prior to their occurrence. The logical next step would be to use relevant information beyond the safety data to combine various types of real-world evidence in order to predict risks for individual patients or patient groups. In this presentation we will discuss attempts to reach this goal.
• Machine Learning/Artificial Intelligence for bias-free identification of risk factors for ADRs
• Types of data available for predictive approaches
• Learning from other medical and non-medical approaches
• Trends
”I really enjoyed the programme and different speakers I had opportunity to hear.
– Head Regulatory Affairs Radiology Medical Devices EMEA, Bayer
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
Sponsors
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Event programme
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