EU Regulatory Affairs – basic training

Training structure

9.00 am – 12.30 pm MORNING SESSION
14.00 – 17.00 pm AFERTERNOON SESSION

Program

09:00  Welcome, introduction and technical check

09:15 – 10:20 Drug Development, Regulatory information & interaction, EU law and guidelines

• Drug Development
• Regulatory & Important websites
• Regulatory Interactions
• EU law and guidelines

10:20  Coffee break

10:30 – 11:30  Dossier – Content in a common format

• Content of Dossier
• Modules
• Summaries and Overviews
• eCTD
• Online Platforms

11:30  Coffee break

11:40 – 12:30  Legal Basis, Module 1 and Product Information

• Legal Basis
• Overview of Module 1
• Product Information

12:30 –  14:00  Lunch

14:00 – 15:20 Regulatory Procedures

• Centralized Procedure
• Decentralized Procedure (MRP/DCP)
• National Procedure and Repeat-Use Procedure

15:30 – 17:00  Regulatory Aspects of the Lifecycle of a Drug

• Variations
• Line extensions
• Renewals
• Referrals
• Other Post-Approval Procedures

17:00  End of seminar

This online-learning course is designed for individuals new to the field or those seeking a career transition into regulatory affairs or those need a basic knowledge of Regulatory Affairs: project managers, project team members, innovators and entrepreneurs, academic researchers, drug developers and management working in research-based pharmaceutical companies.

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.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. 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.

Training cancellation

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.