Sharing Current Best Practices and Strategic Approaches within Pharmacovigilance Regulated Activities
The Nordic Pharmacovigilance Day has become a very popular forum for a broad range of professionals engaged in strengthening the safety of medicinal products and medical devices.
The 8th edition will build on the experiences from previous successful conferences presenting a program covering the current most important topics and challenges encountered within the pharmacovigilance area. Knowledgeable experts will provide excellent updates in key areas, covering recent advances in technology, science and legislation, as well as practical aspects. Sessions will be interactive and participants will be able to ask questions, engage in a dialogue and also share their own experiences.
Among others, we will cover the following topics:
- Industry and regulatory perspectives, including IT perspective
- Current trends including special features during the pandemic
- Medical device and combination product – the PSUR document
- Pharmacovigilance requirements post-Brexit (e.g. PSMF)
- Artificial Intelligence
- AI & Machine Learning
- AI applied in signal detection and safety data analysis
- Outsourcing of pharmacovigilance tasks
- Pharmacovigilance operations in Headquarters vs. Affiliate
Who should attend?
The conference program is designed for healthcare professionals or pharmacists in safety surveillance units in the pharmaceutical industry or regulatory agencies, either as specialists or managers, QPPVs, inspectors and QA personnel including auditors, employees in regulatory affairs units with close relations to pharmacovigilance, sponsors, vendors and CROs, representatives from patient organizations.
Wasim Anwar, Vice President & Deputy QPPV - Head of QPPV Office, Global Safety at Novo Nordisk A/S
Caroline Sandstroem, Senior Specialist GCP/GLP/GVP, Compliance Global QA R&D at Ferring Pharmaceuticals
Doris Irene Stenver, Independent Pharmacovigilance Adviser, Founder of Unique Advice
The Conference is planned to be a one-day on-site event located in Copenhagen, unless the current state-of-play of the Covid-19 pandemic only allows for a on-line event.
Caroline Susanne Sandström
Mikael Juul Bygsø
Marie Fogh Hansen
Ea Marie Holst
Operations and Training Assistant
Quote di iscrizione
€ 670,00* Early Bird fee until October 29th, 2021
€ 790,00* Ordinary fee
€ 430,00* Freelance, Academy, Public Administration
* for Italian companies: +22% VAT
Fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, networking lunch, 2 coffee breaks, organisational office assistance, certificate of attendance.
Park Inn by Radisson Copenhagen Airport
Engvej 171, 2300 Copenhagen S, Denmark
Park Inn by Radisson Copenhagen Airport is situated near both the Copenhagen Airport and the city centre. If you arrive by car, this hotel’s location in Copenhagen, Denmark provides free parking. The nearby metro and train stations are convenient for cyclists and guests without cars.
Metro station Femøren (two stops to airport and six to city centre) – beside hotel
Copenhagen International Airport – 3 km (5 min by metro)
Copenhagen Central Station – 7 km (10 – 15 min by car)