Gabrielle Wiederkehr, a licensed pharmacist from the Swiss Federal Institute of Technology (dipl pharm ETH) is the managing director of ACCESS Regulatory Consulting GmbH. She started her consulting business after a 30 years career in global Drug Regulatory Affairs in leading pharmaceutical companies, most recent positions include VP International Regulatory Affairs at Bayer Consumer Care; VP Regulatory & Medical Affairs, Acino Pharma; Head Global Drug Regulatory Affairs, Novartis Pharma Business Unit Ophthalmics. She is a member of the Executive Committee of the FIP Industrial Pharmacy Section (IPS). Her experience includes development and life cycle management of prescription drugs, generics, consumer care products (OTCs, food suplements, medical devices, cosmetics) resulting in worldwide approvals with target label claims. Also she was leading preparation and execution of meetings with major health authorities globally. In the course of her career she led and designed organizational restructuring and integration (structure, processes, tools, location) at headquarters and in affiliates in context of mergers and internal business alignments. Also she was a member of senior executive boards and leadership teams and acted as company representative in Industry and Trade Associations.