key information
- Location: Hotel Hyperion Basel, Switzerland
- Part of the Pharmacovigilance World Tour
- November 29-30, 2023
- 8:30 - 17:30 Local Time
OUR CONFERENCE PROGRAM
KEY TOPICS
- Pharmacovigilance of advanced therapies
- Stepping up the global game in PV reporting strategies
- Outcomes of rising public awareness: social media and mobile apps in pharmacovigilance E2B(R3) implementation, are you truly compliant? EudraVigilance and FDA case studies
- Soft skills in world of regulations: interactive workshop
- Creating a talent pool for the next generation of pharmacovigilance- is your job at peril? EMA and NCAs guidance during COVID-19 pandemics and vision in the post-covid era
- Natural Language Processing as a necessary tool in PV reporting
- Navigating PV disruption and skills required to survive
- Struggle to minimize costs with new technology: transfer smarter, not costlier
- The vision of outsourcing in the pharma industry: current and future trends
- Drug safety in oncology: consequences of accelerated approvals in Europe
- An innovative roadmap to the adoption of marketed pharmacovigilance automation and Artificial Intelligence (AI) with a focus on efficiency ROI
- PV audit storytelling session – Inspection insights from a global perspective
- Enhancing PV compliance in a joint partnership for a product marketed in differently regulated markets
Who will attend
- 25% Industry consultants, Academia & Solutions and Software providers
- 75% Big & SME Pharma and Biotech companies
Event Speakers
Petros Mavrogenis
Novartis
Sabine Poltermann
BMS
Dimitris Zampatis
Sandoz
Luvanka Hanxhari
Ricarda Tiemeyer
Biogen
Fiorenza Gaudenzi
Marina Suvakov
Philip Morris International
Santanu Mukhopadhyay
Vectura Fertin Pharma
Ján Škrle
Zentiva
Dmytro Horilyk
DrugCard
Jost Leemhuis
Sibel Guerler
BMS
Erika Barbarossie
Gilead
Henk Streefkerk
Amarna Therapeutics
Mark Waring
Graeme Ladds
Pharsafer
Finn B. Larsen
Sandoz
Nikolina Nuic
Philip Morris International
Felix Arenallo
Roche
Galina Cordero
Novartis
REGISTRATION
Conference
Ticket | November 29-30, 2023-
Access to All Conference Sessions of the 9th Annual European Drug Safety Pharma & Biotech Conference Basel
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Access to Post Conference Networking
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Conference Materials
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Includes Coffee Breaks, Snacks and Refreshments, Seated Lunch
BECOME A PARTNER
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Hold an exhibit at this event
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Gain exposure through alternative partnership benefits
event partners
Founded in 2003 by Dr Graeme Ladds, PharSafer® is a specialist Contract Research Organisation (CRO) in Global Clinical and Post Marketing Drug Safety, and Medical Services, with a wealth of experience in Pharmacovigilance, Auditing and Medical Affairs – and the various, numerous and extensive legal safety/medical obligations for licence holders to comply with – as well as Regulatory Strategy for the best methods for obtaining scientific advice concerning licence submissions and approvals.
Our ability to offer first-class services in Pharmacovigilance, Regulatory Strategy, Training, Auditing, Medical Affairs and IT Informatics means that, for many clients, we operate as their Pharmacovigilance and Medical Departments, guiding them through the labyrinth of drug safety and medical legislation – all in the interests of ensuring patient safety safety and client compliance.
Dr. Waring, a licensed physician with extensive clinical and research experience, specializes in clinical drug safety, pharmacovigilance, and pharmaceutical risk management. With nearly 25 years of industry and consulting experience, he has designed and prepared numerous risk management plans for a wide range of products. He has a strong track record of delivering high-quality results on time, meeting regulatory expectations, and has expertise in global and EU pharmacovigilance requirements. Dr. Waring has also led quality improvement initiatives and provided training and coaching in pharmacovigilance and pharmacoepidemiology. His areas of interest include drug hepatotoxicity evaluation and the safety of biological therapeutics.
The Ennov Group is a software vendor specialized in pharmacovigilance, clinical trials management (Data Management, eCRF, Monitoring, Randomization), document management, regulatory submission lifecycle (eCTD), and business process management (Deviation, CAPA, Audits, Change Control, Training).
Headquartered in Paris, with offices in the US, UK, Tunisia & Vietnam, Ennov provides an intuitive and unified content and information management platform to support and enrich the entire Life Sciences product life cycle. It offers comprehensive and flexible tools helping you align your daily activities with respect to the regulatory requirements of the pharmaceutical industry (ICH, EMEA) and FDA recommendations (21CFR, part 11). With more than 250 customers worldwide in Life Sciences, Ennov has become “the solution of choice” in the international software for pharmaceuticals market.
DrugCard is the vanguard in AI-enabled pharmacovigilance solutions, modernizing drug safety practices across the globe. Our platform is designed to automate local literature screening, making it continuous, regular, transparent, multi-language, and cost-effective. And Why Choose DrugCard?
– AI-Enabled Efficiency: Leveraging advanced AI technology, DrugCard streamlines drug safety routines, reducing literature screening time by an impressive 70%.
– Global Reach with Local Expertise: DrugCard supports 100+ languages and covers medical journals in 45+ countries.
– Customizable Solutions: The only SaaS in the market that tailors its features to meet your specific needs. From automatic translation to user role management, we offer a suite of customizable features.
– Real-Time Analytics: platform provides real-time analysis, enabling pharmacovigilance teams to proactively identify new safety signals and evaluate risks, thereby enhancing patient safety.