Christian Schneider is the Chief Medical Officer of Biopharma Excellence, and was formerly the Chief Scientific Officer at the UK’s MHRA. He was the Medical Head for Licensing at the Danish Medicines Agency, and a member of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. In this podcast, we discuss the continuing challenges to Europe’s Biopharma competitiveness, and how an improved regulatory environment could be a benefit. Christian also highlights both the risks and opportunities of the EU’s proposed revision of the general pharmaceutical legislation. This podcast was supported by The European Federation of Pharmaceutical Industries and Associations (EFPIA) and has been recorded in collaboration with PharmaLex GmbH. It is not meant to serve as legal advice and may contain certain marketing statements. PharmaLex and its parent, Cencora, Inc. strongly encourage listeners to review all available information and to rely on their own experience and expertise in making decisions with regard to the information discussed today. 00:00:01 Introduction 00:01:05 What's your day like as a regulator? 00:09:48 Patient access to novel and effective treatments and patient engagement with the EMA. 00:11:40 Availability of data and clinical trials. 00:14:12 Clinical Trials Regulation. 00:15:19 Europe's loss of competitiveness and its role as an innovator. 00:16:36 The importance of Scientific Advice. 00:17:28 Revision of the EU Pharmaceutical legislation: Fostering innovation and streamlining the regulatory process. 00:20:32 Europe losing ground vis-à-vis the USA: Regulatory assessment. 00:27:37 The use of drug-device combinations. 00:32:30 Reimbursement and pricing decisions and criteria for (High) Unmet Medical Needs. 00:41:02 Revising EU Pharmaceutical legislation and creating a future-proof framework for clinical trials and R&D investments. 00:44:15 Ability of Member States to access all medicines. 00:46:27 Recommendations to the European Commission and the EMA on the EU Pharmaceutical package. See omnystudio.com/listener for privacy information.

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