TheEUClinicalTrialsDirectiveWhatnextforthepharmaceuti：欧洲临床试验指导未来的药物.pptVIP

The EU Clinical Trials Directive: What next for the pharmaceuticals industry?RAPS Annual ConferenceWashington DC 11 October 2004 Linda Horton, JD, LLM Hogan Hartson L.L.P. Brussels and Washington, DC What was not new Much was not new, due to: Existing Member State requirements Declaration of Helsinki, ICH guidance, Council of Europe, FDA requirements etc. Global SOPs of global companies Sponsor Responsibilities:Not much new, but articulated Quality Assurance and Quality Control (written SOPs) Appropriate Medical Expertise Trial Design Trial Management, Data Handling, Record-keeping Investigator Selection Monitoring Notification/Submission to Regulatory Authorities Confirmation of IRB/IEC Review Investigational Products Good Manufacturing Practices Ongoing Safety Evaluation/ Adverse Event Reporting EU-level requirements for Ethics Committees Ethics Committee opinions Single opinion per Member State Increased responsibilities and increased professionalism “Unfunded mandates”? decline in number? Commission guidance on applications for Ethics Committee opinions, especially Information given to trial subjects Protection of personal data Lead investigator in Member State In each country, sponsor must decide how to handle the requirement for a “single” Ethics Committee opinion to go to the Competent Authority. This requirement has led sponsors to designate one investigator to be the lead national investigator. The term “principal investigator” is used as the lead person at a site so that term does not work to describe this individual. Oversight: Notification To commence trial: Need OK from Ethics Committee, and No disapproval from competent authority Must have prior approval for gene or somatic cell therapy, genetically modified organism products May need prior approval for certain products (e.g., biological products of human/animal origin) Oversight: Notification To Ethics Committee(s) and Competent Authorit(ies) Significant protocol amendments e.g.,