Aligning external studies with corporate medical strategies and managing regulatory
compliance to ensure successful management of investigator initiated studies

About the Event:

As medical device manufacturers continue to engage with investigators in external research to support new and existing products, the focus of monitoring these studies has never been more important. Working with investigators from the initial phase of the study and remaining engaged with the study site throughout the duration of the trial in order monitor the progress, to assess the outcomes as well as assist in meeting deadlines is a top priority for every manufacturer. These studies also involve significant investments and often fall out of the scope of a products stated use, because of which there are considerable financial and regulatory parameters that are vital to ensure a compliant IIS program. With many challenges to overcome in order to successfully design, collaborate and execute an investigator initiated study, there is much value in meeting as an industry to discuss best strategies to ensure maximum outcomes.

Building upon the tremendous success of our first two annual meetings, TT Group Worldwide is proud to introduce the 3rd Annual European Medical Device Investigator Initiated Study Meeting. The two-day meeting will cover the entire Investigator Initiated study process in-depth and will help attendees gain insights on the best practices and strategies for deriving the greatest possible value from these research programs.

This meeting will also focus on the key changes in ISO 14155:2019 and will also discuss the new European MDR where attendees will have the opportunity to engage in a direct dialogue with Notified Body representatives to understand the regulatory requirements to ensure compliance. Through highly interactive presentations, case studies, roundtable discussions and panel debates, attendees will be able to build a well-rounded plan to improve their IIS initiatives.

The Key Highlights of the meeting are:

  • Gain insights from industry experts about the best strategies for successful management and delivery of investigator initiated studies.
  • ISO 14155:2019 - Examine the regulatory requirements to ensure compliance while initiating external studies for maximized study outcomes
  • Gain insights on how to effectively integrate Real World Evidence (RWE) into investigator initiated studies
  • Learn from industry peers, regulatory experts and legal advisors to safeguard against future challenges and gain opportunities within external studies
  • Get answers to all your queries about the new EU regulations through an uninterrupted Q&A session with senior representatives from competent authorities and notified bodies
  • Discuss and share solutions for aligning investigator initiated studies with corporate medical strategies for achieving business goals

Key Speakers:
  • Dr. Susanne Gerbl-Rieger, Director of Clinical Audit, Clinical Centre of Excellence (CCE), TÜV SÜD PRODUCT SERVICE GMBH
  • Niamh Lynch, Senior Scientific Certification & Inspection Officer, Medical Device & Convenor of Global Risk Management, ISO Standards Group TC262, NATIONAL STANDARDS AUTHORITY OF IRELAND (NSAI)
  • Art Pilmeyer, Director Medical Affairs, BOSTON SCIENTIFIC
  • Fredrik Ceder, Head of Clinical Operations, COLOPLAST
  • Dr. Torsten Böhler, Manager Clinical Affairs, STRAUB MEDICAL AG
  • Jozef Tanczos, VP Clinical Affairs, Europe, MIRACOR MEDICAL SYSTEMS SA
  • Klaas Van 'T Klooster, Clinical Research Manager, DEPUY SPINE INTERNATIONAL
  • Dr Isabel Diterich, Clinical Research Manager, NOBEL BIOCARE SERVICES AG
  • Rahel Meister, Senior Clinical Study Manger Clinical Operations, SMITH & NEPHEW ORTHOPAEDICS AG
  • René Kok, Vice President Medical Affairs, NEMO HEALTHCARE
  • Jessica Bettführ, Clinical Affairs Manager, MATHYS LTD BETTLACH
  • Dr. Frank Emde, Director Clinical Affairs, KAVO DENTAL​​​​​​​
And many more.

Who should attend:

Within the medical device industry, organisations that will find this program of greatest applicability will be those charged with the responsibility of identifying, reviewing and managing investigator initiated research requests and the overall conduct of the external investigator research.
  • Medical Affairs & Medical Strategy
  • Chief Medical Officer
  • Clinical Affairs & Research
  • Medical Directors and Advisors
  • Medical Science Liaisons
  • Legal Affairs & Counsel