The training “Preclinical studies in drug registration: focus on toxicology guidelines and CTD structure”, will give an overview of the current toxicology guidelines, starting with the requirements of ICH M3 (R2) ‘Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals’. The regulatory requirements of toxicology studies will be examined. Furthermore, the correlations between these studies, subsequent clinical development and the registration dossier, in terms of expectations of the European Health Authorities will be explained.
Finally, the recommendations of the ICH guideline M4 (R4) “on common technical document (CTD) for the registration of pharmaceuticals for human use – organisation of CTD – M4S” will also be addressed.
The programme of this training is designed for professionals working in both the regulatory affairs and development departments, to deepen their key knowledge and help them perform efficiently and effectively as interface between multiple entities inside and outside of the company.
ARE YOU INTERESTED IN REGULATORY AFFAIRS TRAININGS?
Sign up for 3 courses and you’ll get a 15% discount*, while if you choose 5 courses you’ll get a 20% discount*. You may choose from these trainings:
- Impact of variations on the site regulatory and compliance activities
- La registrazione di un farmaco: focus sulle linee guida di tossicologia e struttura CTD per la sezione preclinica
- Skilful drafting of technical documentation
- Drugs registration requirements in extra-EU countries
- Basic training in Regulatory Affairs
- Common Technical Document (CTD) module 3: focus on the most critical aspects
- Marketing Authorization Holder (MAH), Regulatory Affairs and Qualified Person: responsibilities and interactions for GMP compliance
(*) discounts apply to full prices and cannot be combined with other promotions. The promotion is valid for the enrollment of the same attendee in 3 or 5 courses among those proposed.
Key points of the training
- Be updated on the current regulatory reference standards on toxicology studies for drugs registration
- Learn about the structure of CTD modules 2.4, 2.6 and 4
- Understand the correlations between toxicology studies and clinical studies
- Understand the regulatory requirements on toxicology studies to be compliant with, to obtain the authorization from European Health Authorities
- Understand how to reuse old toxicology studies for a new registration
09:00 – 13:00 COURSE SESSION
- Acute toxicity
- Repeated dose toxicity
- Long-term toxicity
- Reproductive toxicity
- Multigenerational studies
- Pediatric development
- Other possible toxicology studies
Regulatory requirements of ICH M3 (R2) “on common technical document (CTD) for the registration of pharmaceuticals for human use – organisation of CTD – M4S”
- Modules 2.4 e 2.6
- Module 4
Personnel involved in the pharmaceutical sector: Regulatory Affairs, Preclinical 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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