Central and Eastern Europe continues to be an attractive place for conducting clinical trials, with rapid patient recruitment and high quality of data. At the same time, the clinical trial industry's single greatest challenge continues to be the regulatory process, which has a key impact on the duration of the study start-up period and on timely patient recruitment.

Regulatory requirements in CEE countries went through dynamic changes within the last couple of years, mostly as a result of the accession of several countries to the European Union, as well as increasing demand for the adjustment of local regulations to international standards coming from the pharma industry. However, regulatory changes still seem to be an ongoing process, and the greatest challenge for sponsors and CROs.

This presentation focuses on major regulatory-related problems, with special attention to site contracting problems, and show practical ways of overcoming them in order to speed up the drug development process.

This audio conference covers:

• Ongoing and recent challenges in the CEE regulatory process, including timelines & document requirements
• Lengthy site contracting processes and tips on how to speed it up
• Costs related to the regulatory process
• Regulatory advantages of CEE compared to other regions
• Directions for the evolution of the regulatory environment in CEE in the near future

About the speaker:

Dr. Malgorzata Szerszeniewska is currently CEO of Unimed, a CRO based in the Czech Republic with operations in several Central & Eastern European countries. Previously, she was president of AbCRO, Inc., an American-owned CRO also operating in Central and Eastern Europe. Prior to that Dr. Szerszeniewska spent more than 10 years at Covance, where she held various positions including Regional Resource Manager, Project Manager, Director of Strategic Development and Clinical Operations in CEE, and was responsible for development of the company's Clinical Development Services in the region.

Before joining Covance, she worked as an Anesthesiology and Intensive Care Specialist at Warsaw University Hospital. Dr. Szerszeniewska's therapeutic experience includes indications in oncology, anesthesiology, immunology, neurology, gynecology, urology, cardiovascular, psychiatry, ophthalmology and gastrointestinal medicine. Dr. Szerszeniewska received her Medical Diploma from the Warsaw Medical University.

Who should attend?

• Clinical Operations Managers
• Regulatory Managers
• Project Directors
• Project Managers
• Contract Managers

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

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