Kinesys Regulatory Advisory Board – Safe Harbour Scientific Advice Meetings with our ex Regulatory Agency Assessors
At several stages of development of a new product, negotiation and agreement through Scientific Advice on the overall development programme to support registration is highly recommended. It is critical to secure EMA, EU National Competent Authority (NCA) and FDA agreement on the product development programme. The outcome of a Scientific Advice meeting therefore directly influences the time to market and the cost of development and, as such, is a critical step for all sponsors.
However, time and resources are often not ideal to engage in this intensive and important exercise. Sponsors also often feel that their plans may not be adequately developed to propose to regulators, the risk being that the written advice provided by regulatory bodies on draft plans is not appropriate and sets expectations that the sponsor, ultimately, cannot fulfil.
In these situations, the Kinesys Regulatory Advisory Board can provide clients a safe harbour environment to provide similar advice on the client’s development programme and on specific scientific questions as would be provided by EMA, EU National Competent Authorities, or FDA. Kinesys Regulatory Advisory Board prepare by reviewing all data and documentation relevant to the client’s development programme. We prepare challenging, well-considered questions to put to the client’s team. A meeting is arranged, preferably face-to-face, of 4-8 hours duration depending on the scope. During the meeting the client presents the “Scientific Advice” questions and positions. Our Advisory Board interrogates the company positions in a constructive discussion with the client and provides advice on how best to design the development programme and individual studies, preparing the client for formal Scientific Advice at EMA, FDA or NCAs. The meeting is fully minuted by the Kinesys Regulatory Advisory Board.
Support to address issues raised by the SAWP or NCAs & prepare your team for an Agency interaction
Our Kinesys Regulatory Advisory Board can help you prepare to address the list of issues raised by CHMP / SAWP and for a Discussion Meeting during Scientific Advice. Similarly, with our experience and expertise we can help clients prepare for meetings at National Competent Authorities. Kinesys Regulatory Advisory Board will provide specific experts and conduct challenging mock meetings to better prepare your team for these meetings. Our experts will adopt the role of CHMP / SAWP members or NCA Assessors and challenge you in a “real” setting in order to prepare you scientifically and psychologically for these important meetings that typically define the time and cost of your development programme.
The EMA Scientific Advice procedure has a 40 or 70 Day timetable, depending on the need for a Discussion Meeting. Lead times for NCA Advice vary across member states, as does the documentation required to be submitted at the time of the NCA meeting request. In both cases – EMA and EU NCA – a comprehensive Briefing Book setting out the background to the product development and questions / company positions, is required before the procedure starts. Whereas for EMA Scientific Advice, the decision on whether to call a Discussion Meeting is at EMA / CHMP discretion, for NCA Scientific Advice procedure a meeting can usually be requested by the sponsor / Applicant. National Agency experts will participate according to the nature of advice requested by the sponsor.
Mock COMP, PDCO, PRAC Meetings with our ex Regulatory Assessor support
Similar to Scientific Advice and mock CHMP meetings, Kinesys Regulatory Advisory Board can help you prepare for interactions with the Orphan, Paediatric and Pharmacovigilance Committees at EMA with our ex Agency Assessors and expert Kinesys Project Team. These have a similar set up to the Scientific Advice safe harbour meetings in which our team prepares for a half- to full-day meeting with our clients and constructively questions the client’s proposed approach to responding to Agency Committee objections. Full minutes and follow-up discussions are provided.