The International Standards Organization (ISO) has finally done it: they just published the new ISO 14155 "Clinical investigations of medical devices in human subjects—good clinical practices" (2011). You can buy your very own copy at www.iso.org for 158 Swiss francs, search for 14155.
The new ISO 14155 contains significant changes compared to the 2003 version. Once the standard is harmonized via publication in the Official Journal of the European Union it comes into force immediately. Beware, time is limited to get up to speed with these new requirements and failure to do so will definitely lead you to serious non-compliance issues and possible subsequent problems with getting your clinical investigations up and running in Europe and/or your data accepted for CE-mark.
What will it mean for your study? It will be tough, so you should start updating your procedures for European studies now. You need practical tools for immediate compliance, that this course will provide.
Benefits to the Participants
- Learn what are the primary changes in European regulations and how they affect your study.
- Learn how the new ISO14155 standard for medical device clinical investigations will help you to plan every step of your trial.
- Discover what are the new requirements and responsibilities
- Find out what are the primary steps and how to update your procedures for compliance.
Issues to be covered
UNDERSTANDING YOUR DUTIES
- Directive 2007/47/EC: a new age for clinical research professionals.
- What are the new European regulations and how they will affect you.
- The new ISO 14155. Why changing? What is the effect on our job?
- New requirements and responsibilities for industry and investigators
- Determine how to select and train your clinical staff
- Outsourcing clinical duties: what to expect from CROs and monitors.
- Update your clinical procedures to ISO 14155:211
- Approach the Ethics Committee: expectations for submissions and reviews
- Prepare the informed consent: revised structure, contents, dealing with special cases
- Plan the clinical trial: risk assessment, study justification, protocol, dossier.
- Develop training strategies for your staff and clinical investigators.
- Execute and monitor your study.
- Adverse Events: new definitions, how to classify and report.
- Complete your trial and report results.
- Course slides
- New European Directives, Consolidated text
- New ISO 14155 (training tools)
- Template for monitor training
- Template for developing Informed consent
- Template for Investigator Brochure
- Flowchart for Adverse Event Reporting
- Article: Good clinical practice for device trials (RAPS journal)
Who should attend
- Clinical program directors, project managers, monitors
- Medical doctors and scientists involved in the development of clinical dossiers
- Regulatory professionals in charge of quality assurance and vigilance
- Venture Capital:
- Managers and device industry representatives who need information for strategic decisions and resource allocation
- CROs and clinical monitors:
- CROss and clinical monitors who need to understand the implications associated with acceptance of the duties delegated by the sponsor according to new ISO 14155.
About the Speaker
Dr. Monica Tocchi is a member of the Technical Committee for the development of international standard ISO 14155 for medical device clinical investigations and ISO 5840 series for surgical and minimally invasive cardiac valves. She serves as the Executive Medical Director of an international contract research organization, Meditrial, and works with leading medical industry companies in developing and managing their clinical studies. She is a physician with a specialization in cardiology and a Ph.D. in Cardiovascular Pathophysiology. She has served as a clinical investigator at prestigious medical centers in Europe and the US. Dr. Tocchi has authored landmark studies published in peer-reviewed US scientific journals.
Contacts: email@example.com www.meditrialeurope.com