PDCO Oral Explanation  

Expert assistance to prepare your meeting with the Rapporteur and PDCO.

The Paediatric Investigation Plan (PIP) is a critical element of any MAA. Without an approved PIP, the MAA will not pass validation and will not be assessed, even if it is focused on an adult indication only. The procedure can take up to a year with clock stop and it is essential to thoroughly prepare any meetings with the Paediatric coordinator, Rapporteur and PDCO members.

When, in some cases, at the end of the procedure, before or during the MAA, a negative opinion is adopted by PDCO the Applicant may still have an opportunity to appeal the decision. The applicant would have to submit a written request citing detailed grounds for a re-examination of the opinion.

Within 30 days following receipt of this request for re-examination, the Paediatric Committee, having appointed a new Rapporteur and peer reviewer, shall issue a new opinion confirming or revising its previous opinion.

The Applicant will have the opportunity to discuss with the Rapporteur and peer reviewer and may also be invited to an Oral Explanation in front of the PDCO during the re-examination procedure.

These interactions will be critical for a positive outcome of the procedure and to the successful submission timelines, of a MAA so all interactions and meetings must be carefully planned.

Kinesys Regulatory Advisory Board

Kinesys Regulatory Advisory Board can help you with all the preparation before meeting with the Rapporteur and PDCO. Similar to other procedures, we will put your team through challenging Q&A sessions simulating the real meeting so that your team’s message is not only finely tuned in its medical and scientific content, but also in its communication strategy.