GDPR regulation became effective on the 25th of May 2018 and it forced many companies to review their system, operations and processes to make sure that company are not at risk of paying high penalty. In case of non-compliance, a penalty could cost up to 20 000 000 EUR, or up to 4 % of the total worldwide annual turnover of the preceding financial year.
After many hours of debating with legal and management teams, each company had to decide what is the best solution to be able to collect sufficient safety information which is a legal obligation for each Marketing Authorization Holder from one site and to follow the data minimization principle described in the GDPR regulation on the other site.
• How to address the lawfulness, fairness and transparency of processing principles?
• What would be the best solution for your system?
• How other companies addressed this important question?
• What is the Health Authorities approach towards processing of personal data for PV purpose?
• Do we need to include privacy notes?
These and many other questions will be discussed during the presentation, as well as examples from the expert network.
As a Head of PV Strategy Office at Global Patient Safety at Merck (Darmstadt, Germany), Dr. Julia Appelskog is focusing on the strategic initiatives, innovation and integrated quality management system within Pharmacovigilance.
She has more than 17 years of experience in Pharmacovigilance and 8 years of experience in biomedical research. Previous roles include EU QPPV and Head of Pharmacovigilance at Bluefish Pharmaceuticals, and senior PV positions within large pharma companies, such as MSD, Johnson & Johnson and Sanofi Pasteur MSD. Her expertise spans the entire product life cycle covering medicinal products, including biopharmaceuticals and vaccines, medical device and cosmetics. She has been involved in variety of intervention and non-interventional epidemiological and clinical trials and was responsible for the Quality Assurance, Regulatory Affairs and Medical Information.
Dr. Appelskog has accomplished a PhD Thesis in cell biology at the Karolinska Institute (Sweden) in 2001, focusing on diabetes research for 8 years. She has been a postdoctoral fellow at the Department of Clinical Neuroscience at Karolinska Institute, conducting research on epigenetic mechanisms, modification of DNA and its associated proteins in tumor cells.
Julia is currently a member of EMA EudraVigilance Working Group (EWPWG), EuropaBio, International PV Working Group (IPWG) at EFPIA. Previously, she was a member of PV Committee at Medicine for Europe, the Chairman of PV Working Group at Swedish Generic Medicines Association (FGL), a member of PV Focus Group at AESGP and a member of PV Committee at the Pharmaceutical Industry in Sweden (LIF).