This course is intended for manufacturers who are planning to bring their devices to the European market and need clinical data to support their product claims according with the new EU Directives, which take effect on March 21, 2010. One key change is the requirement of more clinical data for devices placed on the market in any of the 27 EU member nations. For clinical investigations, there will be more scrutiny of clinical dossiers and communication between authorities, for example, refusal from one country will be shared with all other nations. Devicemakers need practical tools for immediate compliance with the new requirements, that this course will provide.

Whether you are developing an innovative product, preparing a technical dossier for CE marking or planning a clinical study in Europe, this course will allow you to tailor your strategy for gathering valid clinical evidence in Europe to reach your business objectives of rapid and cost-effective market approval. If you also plan to enter the United States market, you will receive practical advice on actions that can be taken to prevent costly duplication of studies for FDA approvals and clearances.

• Prepare for the new EU regulations: learn how to demonstrate compliance for approval of a clinical study, CE marking or post-market trials
• Enhance device acceptance: Understand how to enhance device acceptance in routine medical practice and in the clinical community by generating valid clinical evidence
• Clinical investigations: When clinical investigations are needed, discover how to plan and budget the study to reduce time and cost, and how to address risks which can jeopardize the success of your study, such as denial of approval from a Competent Authority, or selection of non-recruiting or non-compliant sites. Learn what will change with the new ISO14155 standard for medical device clinical investigations, expected for public release around June 2010.
• Literature route according to the new MEDDEV Guideline: When relevant literature data from similar products are available, learn how to conduct a Clinical Evaluation in order to provide solid support for the safety and performance of your device and avoid or reduce the need to generate additional data through clinical studies.
• Course Materials: Receive course materials and easy-to-use templates, including:
  • Copy of the new consolidated Directives
  • The new EU guidelines for clinical evaluation and vigilance
  • Guidelines on good clinical practice for sponsors and investigators
  • Adverse event reporting flowcharts
  • Checklists for preparing trial master file and Ethics Committee dossiers
  • Country-by-country information on clinical study submissions
  • A template for preparing clinical evaluation reports

• Regulatory update:
  • New regulatory requirements for clinical studies in the revised Medical Device and Active Implantable Medical Device Directives
  • New MEDDEV Guidelines for Clinical Evaluation and Vigilance
  • New revision of the medical device clinical investigation standard, ISO 14155
• European clinical investigations:
  • Study strategy including study design, intended use, claims, primary and secondary endpoints, patient sample size
  • Planning: timelines, resource allocation and budgeting
  • Development of clinical investigation dossier: protocol, investigator brochure, clinical risk analysis, informed consent
  • Overcoming the challenges for “first-in-man” studies
  • Investigator selection, credentialing and training
  • Investigator agreements and payments
  • Approval process in each EU country: fees, timelines, language and insurance requirements, local challenges
  • Communication with Ethics Committees and Competent Authorities
  • How to optimize study management and monitoring
  • Best options for data management for different types of studies
  • Adverse Event reporting: when, how, to whom
  • Study conclusion & termination
  • Final report
• Clinical evaluation for CE marking:
  • New EU guidelines for clinical evaluation
  • Global Harmonization Task Force guidelines
  • How to conduct a clinical evaluation
  • Objective of clinical evaluation
  • Qualifications of the authors of clinical evaluations
  • Flowchart of the clinical evaluation process
  • Presentation of device claims
  • Criteria for identifying clinical evidence
  • Justification of the relevance of clinical & technical/biologic data
  • State-of-the art literature search using clinical databases
  • Critical assessment of the data
  • Review of template for clinical evaluations
  • Discussion of case-studies
  • Communication and meetings with the Notified Body
  • Preparing for regulatory reviews/audits of clinical data 

• Industry:
  • Personnel responsible for Technical Documentation and regulatory compliance (QA, R&D, Regulatory Affairs)
  • Clinical affairs professionals
  • Project managers
  • Medical doctors and scientists involved in the development of clinical dossiers
• Venture Capital:
  • Venture capital managers and device industry representatives who wish to gather information needed for strategic decisions and resource allocation
• Consultants and clinical monitors:
  • Consultants and clinical monitors who wish to gain in-depth knowledge of the European regulatory climate and build expertise through a specialized course