Regulators from EMA, the FDA, United Kingdom, Ireland, Spain, France, Germany, Italy, Switzerland, Russia, WHO and EDQM Strassbourgwill function as panel members. The panel will be divided into three groups and each group will have a 30 minute time slot dedicated to a specific topic. The sessions will be facilitated by an experienced moderator.
Identified areas of discussion:
- Global inspection and compliance, chances to harmonise, to apply more mutual recognition and to reduce burden of inspections. Moderator: Andy Hopkins, Abbvie, former MHRA
- Global harmonisation of regulation, pharmacopoeias and Technical Standards e.g. for aseptic processing, for mass serialisation, and definitions e.g. drug shortages. Moderator: Ron Ogilvie, Pfizer
- New quality management approaches for existing principles, triggered by new product types, digitisation, Industry 4.0, new processes and new regulation. Moderator: Rico Schulze, Saechsisches Staatsministerium Sachsen