Developing an accurate clinical and regulatory master plan is the key to getting any new drug or device product to the global marketplace quickly and in a cost-efficient manner. The master plan provides an invaluable roadmap of what needs to be done, and will also be used as a business plan in dealings with your notified body and potential investors.

In this audio conference, our speakers discuss not just planning for CE marking, but incorporating the overall global market access into one plan. Attendees learn how key parameters and claims are defined, which is an important starting point. The presentation also covers how to ensure compliance throughout the regulatory pathway to the global market, and how to ensure there is sufficient data available for immediate success of your products in global markets.

This audio conference covers:

• What is the clinical and regulatory master plan?
• Why do you need one?
• What can you do with a master plan?
• What should be in your master plan?

About the speakers:

Efraim Roe Kozorovitsky is Executive Director - Medical Devices with the Premier Research Group. He has spent more than a decade conducting clinical investigations and working with the CE-mark process, sharing his extensive knowledge with companies from around the globe. Prior to joining Premier Research in 2007, Efraim was Clinical Operations Manager with D-TARGET, a CRO specializing in European medical device trials. Before that, he was the Study Manager at BioControl Medical, an active implantable medical device company. In addition, Efraim also worked as a Clinical Research Associate for a leading pharmaceutical CRO, and spent more than 15 years as a volunteer emergency care provider on ambulances and mobile intensive care units in Israel. As a Paramedic (EMT-P) graduate with honors, he obtained an Emergency Medicine degree from the Academic University Ben-Gurion in Israel, as well as an MBA from the Derby University in the UK. He is a published regulatory author and a highly respected conference speaker.

Dr. Sunita Ahir is Regulatory Affairs Manager at Premier Research. She currently advises and supports medical device companies on the CE marking process, authorized representation in the EU and compliance issues. Dr. Ahir has extensive experience in the medical device field, having worked for BSI Healthcare division as a technical expert where she reviewed Class IIb and Class III submissions for CE marking. Her other responsibilities included technical auditing, ISO 13485 and project management of many companies in the medical device field. She has a master's degree from Cranfield University and a PhD in Biomedical Engineering from University College London. Dr. Ahir is an experienced public speaker and regularly presents topics at regulatory conferences.

Who should attend?

• CEOs and COOs
• Regulatory Affairs
• Clinical Operations
• Quality Control & Quality Assurance
• Marketing Managers
• Project Managers

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.