Investigational Medicinal Products, or IMPs, are defined as “a pharmaceutical form of an active ingredient or placebo that is tested or used as a reference in a clinical trial.”
In this context, Regulation (EU) No. 536/2014 “…on clinical trials on medicinal products for human use and repealing Directive 2001/20 / EC” aims to establish standardized regulations for conducting clinical trials in the European Union. This also involved a review of GMP requirements for Investigational Medicinal Products (IMPs). To this end, Directive 2003/94 “…laying down the principles and guidelines of GMP relating to medicinal products for human use and investigational medicinal products for human use” was replaced by two directives: one specifically for commercial products and one for investigational medicinal products. At the same time, specific GMP guidelines for IMPs were issued, replacing Annex 13.
With the activation of the Clinical Trials Information System (CTIS) portal, the Clinical Trials Regulation (EU) 536/2014 is officially operational as of January 31, 2022, leading to a radical transformation of the system and to the harmonized management of the evaluation and supervision of clinical trials in the European Union (EU) and the European Economic Area (EEA).
Also in consultation is the new: “Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice.”
So, what do these changes on IMPs’ regulation entail?
Manufacturing, release, and supply of IMPs: what is new and what are the new perspectives?
Do the GDPs apply to IMPs?
How should the QP, QA, Clinical Supply Manager, or auditor update in this area?
How to handle the interface areas between the manufacturer and the sponsor and what contractual agreements are required?
The training course “EU Updates on IMPs, Investigational Medicinal Products” will answer all these questions.
Key points of the training
- Understand the recent regulatory changes for the management of IMPs
- Grasp the impacts of the new Annex 13 on quality topics
- Understand what has changed for QP
09:00 – 13:00 COURSE SESSION
- Directive (EU) 2017/1572 of 15 September 2017: regulatory context and interpretation
- Regulation (EU) 2017/1569 of May 23, 2017: regulatory context and interpretation
- Guideline on GMP for IMPs for human use versus Annex 13
- Guideline on sponsor responsibilities on the management and shipment of investigational medicinal products for human use in accordance with GCP and GMP.
Personnel involved in the production of IMPs, Quality, Sterility Assurance, Qualified Person, Clinical Supply Manager.
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 firstname.lastname@example.org 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 email@example.com. 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.
Operations Manager Process & Quality
Graduated in 1992 in Pharmaceutical Chemistry and Technology at the University of Siena, she has 30 years of professional experience in pharmaceutical companies and in the world of pharmaceutical consultancy. She began her career in 1992 in the Research and Development of the Technobiochip. Subsequently she worked in Quality Assurance at A. Menarini Industrie Farmaceutiche Riunite (Florence) and in the Corporate Quality Department of the Menarini Group from 1996 to 2000 where she gained experience in the different sectors of Quality Assurance and in Operations. From 2000 to 2009 she worked at Bayer Biologicals (Rosia – SI) where she assumed roles of increasing responsibility up to Plant Manager and Head of Operations. From 2009 to 2011 she was Qualified Person and Plant Manager at Galenica Senese. Since 2012 she has been Operations Manager Process & Quality at Pharma D&S; she is also involved in training activities within Pharma Education Center.
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