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. Web seminar attendees will walk away with tools to help plan, write, and manage multiple CTAs with all their differing requirements.

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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 specific 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

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

Cheryl Vitow

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