Writing and Maintaining the EU CTA (Clinical Trial Authorization)

Course Description

The Regulatory Affairs department must prepare documents that inform European Regulatory Agencies about the proposed development plan; submit a Clinical Trial Authorization (CTA) to initiate human clinical trials; answer questions about on-going investigations; and construct and submit any updates to the CTA in a concise and informative manner. Regulatory submissions are more than just writing – they encompass strategy, research, writing, organizing and leading a team, compiling, editing, publishing, and tracking of the information. When initiating a global clinical trial program, many moving parts need to be brought into harmony to ensure compliance and that timelines are met. Attendees will walk away with tools to help plan, write, and manage multiple CTAs with all their differing requirements.

Learning Objectives

• Navigate Europe’s regulations, directives, and guidelines
• Describe the basic requirements of the CTA, the Investigational New Drug (IND) equivalent in the EU
• Identify the key documents that will be needed for the preparation of each country’s CTA
• Identify the documents required by each country to support the CTA
• Determine the timelines for review by Ministry of Health and Ethics Committees
• Determine what is needed to amend and maintain the CTA including safety and annual reports

Who Should Attend

• Regulatory Associates and Managers
• Quality Assurance Personnel
• Manufacturing Personnel
• Clinical Research Professionals
• Project Managers
• Pre-Clinical Personnel
• Other Members of the Drug Development Team who wish to know more about the global drug development and CTA submission process

Instructor

Cheryl Vitow

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Registration Fees

$835

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 3 hours (0.3 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#: 0778-0000-17-055-L01-P. Released: 5/17. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.