The tutorial analyses each relevant step of the Paediatric Regulation, from the PIP to the reward. It teaches to the participants (i) to assess whether a PIP is needed and, if so, to prepare a PIP proposal which is consistent with the EMA’s new policies, (ii) to best use the paediatric procedures to secure acceptable paediatric studies, (iii) to determine the impact of the paediatric requirements on the (successive) regulatory approval(s) of the product, and (iv) to predict the eligibility for the reward(s) and the steps to undertake to secure their granting.
Who Should Attend
Professionals in the pharmaceutical area involved in regulatory, legal and clinical research
At the conclusion of this tutorial, attendees will be able to:
- Analyse each relevant aspect of the Paediatric Regulation and their interactions
- Assess how the Paediatric Regulation will or may affect the development of their products
- Adapt development plans accordingly and to anticipate possible issues