The EU General Data Protection Regulation (GDPR) came into force in May 2018.
This presentation will give a feedback from Pharmaceutical companies, biotechs, Academic Research organisations and CROs on lessons learned and best practices. We will present also the interpretations of Data Protection Agencies, and their expectations.
We will discuss the interplay between GDPR and existing industry regulations and guidelines (GxP, ICH ePrivacy…). We will look at the impacts for clinical research professionals, and new opportunities arising for them.
Bertrand Le Bourgeois graduated as an engineer from Ecole Centrale in France, with a marketing specialization from HEC Business School.
He has spent his career in Management and IT Consulting, acting also as IT Director and internal auditor for a fresh food company. In the last 18 years, Bertrand has been working in the healthcare and life science industries at major service providers for Clinical Research, Pharmacovigilance and Data Management.
Now Bertrand is President of PharMarketing, a management consultancy providing GDPR, IT and Quality consulting services to the healthcare and life sciences market across Europe. Bertrand is speaking regularly at industry conferences in Europe and in the US.
Bertrand is member of the Board of Directors of the Association of Clinical Data Management and of Data Management Biomedical; he is also an active member of French Regulatory Affairs Association (AFAR) (Data Privacy and Clinical Trials Committees). PharMarketing is member of AFCDP, the French Association of DPOs.