Pharma / Biotech
This two-day course is designed to provide individuals with a detailed understanding of the important regulatory guidelines involved in the development of a new product plan within the EU. The program will also cover effective strategies for correctly applying the current regulations to ensure that rejections are avoided.
The course will provide the attendee with a thorough knowledge of the following topics:
Attendance will be beneficial to personnel involved in new product development who need a thorough understanding of the issues affecting new medicinal products within the regulatory framework of the European Union.
The program will be useful to individuals who are seeking to update their knowledge of recent EMA regulatory changes and the impact these changes will have on the product development cycle.
Introductions & Agenda Review
Regulatory strategy and regulatory plans (including target SmPC)
Pricing and reimbursement
Orphan medicinal products
Advanced Therapy Medicinal Products
Recap, Questions and Answers
Those completing this course will have a comprehensive overview regarding all aspects of regulatory affairs as they relate to product development issues within the EU.
Participants will be able to create a comprehensive regulatory plan including how to obtain orphan medicinal product status from the EMA, as well as when to ask for scientific advice.
Additionally, the topic of how to integrate paediatric studies in the development plan will be discussed along with information regarding the special regulatory aspects of Advanced Therapy Medicinal Products and Oncology Medicinal Products.
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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