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Conducting Clinical Trials In Emerging Regions: Asia Pacific, Eastern Europe, India and Latin America

Please check back later for this seminar's current schedule, or review our other live seminars for similar courses.

Course Description 

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. 

Learning Objectives  

  • 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 

Who Should Attend 

  • This program has been designed for those clinical research professionals who are involved in the planning and execution of global clinical trials. 

Instructor 

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.
 

Click here for complete trainer biographies 

Course Outline 

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. 

Interactive Activities 

  • 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 

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. 

 

Click here for our seminar cancellation policy 

Accreditation Information 

ACPE LogoBarnett 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. 

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2012 GCP Question & Answer Guide Print Edition 

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CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

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PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)