Planning and Conducting Global Clinical Trials

Increased competition for clinical trial subjects and resources has spread investigational sites and vendors all over the world. This globalization of clinical trials has helped sponsors to control drug development costs and timelines, but at the same time has generated new challenges for sponsors. This course provides a comprehensive overview of the considerations for planning and conducting trials outside the United States. Expectations of the FDA, EMA, and MHLW for trials conducted outside their regions are reviewed. Strategies for meeting these expectations in the context of differences in clinical research experience, patient populations, medical practice, language, culture, legal and regulatory requirements, logistics, and technological capacity are discussed. The course includes specific operational strategies for clinical trial implementation in both developed and developing countries.class="Abstract"

• Summarize the trends in globalization of clinical trials
• Explain the impetus for globalization of clinical trials
• Identify the factors supporting globalization of clinical trials
• Understand the impact of the FDA’s, EMA’s, and MHLW’s expectations on global clinical trials
• Assess the issues critical to planning a global clinical trial
• Identify key variables for understanding local clinical research environments
• Recognize the differences among countries that may be advantageous or challenging to clinical trial sponsors
• Develop capacity for working in a multicultural environment
• Predict the challenges involved in global clinical trials
• Formulate strategies for meeting the challenges

• Experienced clinical research professionals who want to develop skills in planning and conducting international clinical trials.

The course will be led by one of the following instructors:

Anne McDonough, M.P.H., C.C.R.A., M.I.C.R.

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Day 1: 8:30 a.m. – 5:00 p.m.

• Globalization of Clinical Trials: Where are clinical trials being conducted? Why are clinical trial sites and services moving around the world?
• FDA Rule on Foreign Clinical Trials/EMA Reflection Papers/MHLW Basic Principles on Global Clinical Trials: What are the impacts of these documents on the planning and conduct of global clinical
  trials?
• Considerations for Planning Global Trials: What are the ethical, scientific, and practical considerations for global clinical trial design and country selection?
• Understanding the Local Environments: What do we already know? What else do we need to find out? How do we get this information? How can we perform successfully in a multi-cultural environment?

Day 2: 8:30 a.m. – 5:00 p.m.

• class="Abstract"Regulation: How can we ensure compliance with the local clinical trial regulations?
• Legal: What other kinds of laws affect clinical trials? How do we manage contracts and insurance?
• Abstract"Language: What needs translation or interpretation? How do we do it?
• Abstract"Communication: How do we communicate and train in many languages, to people of many cultures, in countries all over the globe, in time zones around the clock?
• Logistics: How do we manage international differences in shipping, technology, and currency?
• Clinical Trial Procedures: What are the considerations for investigational products, study supplies and equipment, informed consent, data collection, monitoring, pharmacovigilance, record retention?

• Brainstorming group discussions
• 12 Golden Rules development
• Small group assignments
• Cross-cultural simulation
• Change planning exercise

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 issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE# 0778-0000-15-005-L01-P. Released: 4/15.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.