The training “Focus on the Module 5 of the Common Technical Document (CTD)” starts with an overview of the legal bases for registration procedures in Europe, with a particular focus on how they affect the structure and content of the CTD. Regulatory requirements, as well as the correlations between toxicology studies, subsequent clinical development, and the registration dossier, in terms of expectations of the European Health Authorities, will be explained. The training will also provide an overview on the clinical development phases of a medicinal product, including post-authorization studies. A focus on the pediatric regulation 1902/2006 requirements will follow, with the aim to illustrate how these requirements can change depending on the legal basis of the registration dossier. Finally, discussion on the guideline on bioequivalence studies will close the training.
Key points of the training
- Learn the legal bases of registrations at a European Level
- Understand how the legal basis affects the content of the registration dossier
- Get an overview of all the phases of clinical development, post-authorization clinical studies included
- Understand the requirements of the pediatric regulation 1902/2006
- Learn about the guidelines for the conduction of bioequivalence studies and which are the fundamental requirements for health authorities
09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION
Legal bases and content of the registration dossier
The clinical development:
- Phases of clinical development
- Pediatric regulation 1902/2006
- Post-authorization clinical studies
- Bioequivalence study CPMP/QWP/EWP/1401/98 Rev. 1 Corr (January 2010)
- Q&A Session
Personnel involved in the pharmaceutical sector: Regulatory Affairs, Clinical Development, Scientific officer.
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
In order to cancel enrolment to an event, please email email@example.com within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
It is possible to replace a participant attendance without additional cost, simply by contacting firstname.lastname@example.org. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Regulatory Affairs Director at Pharma D&S
Graduated in 1997 in Pharmaceutical Chemistry and Technologies at the University of Milan, she gained professional experience in pharmaceutical companies and in the world of pharmaceutical consultancy. Pandini began her career in the regulatory affairs of Rottapharm srl and subsequently worked as RA Senior Officer at Zambon Group SPA. Since 2006 she has been Regulatory Affairs Director at PHARMA D&S and she is also involved in training activities within the Pharma Education Center.
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