In order to speed up the clinical research and product registration process, it is critical to carry out clinical studies outside what is considered traditional countries/regions (United States and Western Europe). However, conducting studies in developing countries requires very careful planning to succeed. Being ready to take full advantage of a global patient population can provide very positive patient access results, and today, emerging regions like Asia Pacific, Eastern Europe and Latin America play a very important role in global clinical trials. Accessing these populations requires an understanding of how to approach cultural differences, language barriers, and their unique regulatory environments.
- Overcome the challenges of conducting international clinical trials in emerging regions
- Consider cultural and regulatory differences and approaches when conducting clinical trials in emerging regions
- Assess the critical issues to be considered at the time of planning a clinical trial in emerging regions
- Identify the key differences in conducting clinical trials in emerged regions versus emerging ones
The course will be led by one of the following instructors:
Anna Filimonova, M.D., Ph.D.
Karen Chu, Pharm.D.
Leylen Colmegna, M.D., Ph.D.
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Day One: 8:30 a.m. – 5:00 p.m.
- Understanding the Central Eastern Europe and Latin American environments
- Clinical Trial Environment and Recommended Countries
- Understanding the Overall Health Care Environment
- Cultural Considerations and Approaches
- Regulatory Environment
- Start-up strategy
Day Two: 8:30 a.m. – 5:00 p.m.
- India and Asia Pacific
- Project Plan development: Study start up and Regulatory plan; Risk Management Plan (including scientific, regulatory, quality and logistic considerations); perform a Study Feasibility Assessment; develop a Patient Recruitment Plan
There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day.
- The workshop is based on a real case study. Attendees are requested to provide sample clinical trial protocols that will be used to customize the training to meet individual participant’s needs.
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-14-003-L01-P. Released 4/15.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.