In Pharmacovigilance, we are entering extraordinary times. Evolutions in technology, regulations, and processes bring along unprecedented challenges as well as new opportunities for all involved parties including patients and their caregiver, the investigators, the health care professionals, the regulators, the sponsors, the vendors and CROs.
While the shorter-term benefits of digitalization are gradually becoming tangible, there are also longer-term aspirations to transform the entire operating model in the field of pharmacovigilance.
For the 7th Nordic Pharmacovigilance Day conference 2020 we are posed with the following questions:
- What are the challenges for our QPPVs – locally and globally?
- What is the impact of the new EU-medical device regulation on pharmacovigilance of devices and combination products?
- What are the Risk Minimization Measures outcomes and how to measure the effectiveness?
- RWE and Big Data - Signal management, how to manage in the best way?
- Inspection Readiness – What are the emerging trends in the field of pharmacovigilance and how to prepare your organization?
- New PV tools, machine learning and AI (data protection and Signal detection – requirements, challenges and compliance). Are we ready to monitor the patient safety in the new digital era?
- Outsourcing in PV, how to ensure oversight and how to be compliant?
The future is here, and we need to shape it to provide enhanced solutions for a better health and quality of life for patients. This meeting is a key opportunity to network and learn from knowledgeable speakers and experts in this area.
Wasim Anwar - Director, Safety Surveillance - Biopharm, Diabetes Insulin & Devices at Novo Nordisk A/S
Caroline Susanne Sandström - Senior Specialist GCP/GLP/GVP Compliance Global QA R&D at Ferring Pharmaceuticals A/S
Doris Stenver - Independent Pharmacovigilance Adviser, Founder of Unique Advice
Who should attend?
All times indicated are Central Europe Summer Time
Caroline Susanne Sandström
Betina Østergaard Eriksen
Events & Training Executive
€ 560,00* Early Bird fee until October 5th, 2020
€ 680,00* Ordinary fee
€ 390,00* Freelance, Academy, Public Administration
* for Italian companies: +22% VAT
Fee includes: access to the virtual conference, organizational support, certificate of attendance, slide presentations in pdf format provided post-event.