Pharma / Biotech
The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections.
The course will also provide the attendee with a thorough knowledge of the following topics:
This course is specifically designed for personnel in regulatory affairs of pharmaceutical and biotech companies who need to acquire basic knowledge or need to update their knowledge regarding filing variations.
This course will provide you with a comprehensive overview of filing variations, as well as addressing new regulations governing variations to national marketing authorisations and work-sharing which went into effect on 4th August, 2013.
Introductions & Agenda Review
Overview of the different types of variations and the different procedures for a Marketing Authorisation in the EU
Variations Type IA and Type IAIN
Variations Type IB
Variations Type II
Variations involving Product Information
Recap, Questions and Answers
CMD(h) recommendations on unclassified variations
Work-sharing between the regulatory authorities
Upon completion of this course, each participant will have a comprehensive knowledge and understanding of filing variations and line extensions. Special attention will be paid to variations involving product information and how to correctly classify variations.
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process.
Accounts are a new feature on our website. Creating an Account helps you view your order history and manage your training programs.
If you are registering for others, please set up an Account in the Attendee’s name. If you are
registering more than one person, you’ll need to set up a separate account for each Attendee.
*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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