“Safety and Pharmacovigilance” increasing Awareness of Significant and Essential Needs in Benelux Countries
The 4th Benelux Pharmacovigilance Day conference will be the opportunity to discuss, deliberate and debate the latest operational and technological challenges in the Pharmacovigilance (PV) and drug safety field. Recent advances and perspectives in PV and drug safety in clinical trials will be shared during the meeting, with an emphasis on practical aspects and how-to. This event brings together the relevant experts to share their experience in the field using practical examples. This will trigger engaging discussions and will guide participants’ efforts in the jungle of currently available methods. The objective is to help find solutions to multiple challenges that, as a cross-functional development team in PV, must solve to maximize new opportunities ahead.
This year’s event focuses on hot topics that have major impact on Safety and Pharmacovigilance related processes and activities such as, but not limited to:
- New inspection mood and audit feedback (PV quality compliance linked to new AI tools)
- New medical device regulation: Impact on safety reporting
- Safety reporting in drug-device combination
- AI in Literature monitoring, new tools
- Assessment of effectiveness of risk Minimization Measures
- Big Data in PV- Signal management
- QPPV challenge & emerging trends linked to Brexit
- New PV tools, Machine learning and AI (data protection and Signal detection – requirements, challenges and compliance) how to capture safety concerns?
- Clinical Trial regulation (CLINICAL TRIALS REGULATION (EU) NO 536/2014 Q&A document)
- PV requirements for health supplements or alternate therapies
During this one-day forum we will provide and discuss the best solutions to help drive success in your organization.
Elena Prokofyeva – Head of Drug Safety Unit at FAMHP
Leanne Walsh - Global Director, Drug and Device Safety Services at Covance
Parminder Kaur - CEO & EU QPPV at RegPak BioPharma Consulting
Who should attend?
This conference is designed to benefit functional/technical professionals working in the pharmaceutical and health care area dealing with the Pharmacovigilance system, such as: Safety and Pharmacovigilance dept, Clinical operation dept, Statistic dept, Medical Affairs dept, Medical Information dept, Regulatory Affairs dept, Quality & Compliance dept, Legal dept, Software Developing dept, Medical Devices Manifacturing Companies, University Faculties scientists who are related to clinical and medical research (Senior, Associate and Assistant Professors, Research Scholars, Phd students). Also, Directors/Seniors Directors/Executive Directors and Vice Presidents /Senior Vice Presidents/Executive Vice Presidents and Heads/Leaders/Partners of: CROs and CMOs, Clinical Research Sites, Pharma, Biotech and Medical Devices Industries.
For sponsorship opportunities, please contact firstname.lastname@example.org
14 Ottobre 2020
Information found in the biomedical literature is a significant source for tracking and reporting adverse drug reactions (ADR). The EMA and FDA have both mandated that market authorization holders maintain active screening of literature for any mentions of ADRs related to their drugs or other medicinal products. Given the increasing amount of international and local literature, screening, reviewing and monitoring literature costs more time, money and creates an additional compliance risk. Embase has introduced the first local language module for French literature as step in standardizing global and local literature surveillance as a single streamlined process. However, the challenge with the amount of data to review and critically assess is still faced by all market authorization holders. To address this, we are testing the use of advanced technologies in Artificial intelligence (AI), Machine learning (ML) and Natural language processing (NLP). Our first step was to develop models to identify Adverse events (AE) in the literature. By ensuring that all relevant information is captured efficiently, the company is helping drug safety and pharmacovigilance teams deliver considerable improvements in health-critical workflows.
Following the latest developments concerning the Brexit, EMA notified all the relevant stakeholders that as of 1 February 2020, “the UK will no longer be able to participate in EU institutions and their decision-making”. After the transition period, the EU Pharmacovigilance map will further change, which in turn will have a significant impact in MAHs responsibilities covering EU and UK based QPPVs and PSMFs, among the other PV tasks.
The objective of this presentation is covering the current status of QPPV and PSMF requirements reflected in the legislations, both EMA and MHRA, activities performed by MAHs, specifically referring to QPPV and PSMF, and transition period – the preparations for proper shaping of PV system. Looking into the future, this presentation will focus on the roles, and the prospect relations between EU QPPV and UK QPPV; EU vs UK PSMF – similarities/differences in format and content – what we know or do not know; and finally, what will UK PV system have in common with other ex-EU countries’ requirements in sense of having a responsible person and document describing the PV system, but never been part of the EU.
Sede della Conferenza
in addition to the hotel venue here is some recommended hotels for accommodation in the nearby:
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and networking lunch will provide a pleasant moment of refreshment and an opportunity for you to network with your industry peers. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
All our conference facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the conference. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click.
All the necessary information for the Conference is provided. The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance.