EU Variations and Regulatory Lifecycle Management

Training structure

9.00 am – 1.0 pm MORNING SESSION

Program

09:00  Welcome, introduction and technical check

09:15 – 10:45  Variations procedures – Part I

• Background
• Category of variations and decision tree
• Recommendation on unforeseen variations (Article 5)
• Types of variations (Type IA / IA_IN, Type IB, Type II)
• Procedural issues and timelines

10:45  Coffee break

11:00 – 11:50  Variations procedures – Part II

• Grouping and work sharing
• Application Form, Cover Letter etc.

11:50 – 13:00  Other post-approval activities

• Line Extension
• Renewals and referrals:
• Other procedures following approval: Articles 45 and 46 of the Paediatric Regulation, transfer of marketing authorisation, post-authorisation measures, procedures for repeated use and change of RMS
• Pharmacovigilance duties

13:00  End of seminar

This online-learning course is intended for anyone working on EU variations, classifying or submitting them to the relevant agency, particularly those involved in regulatory affairs.

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.