Earlier this year, I mentioned we are planning events aimed at helping applicants submit that all elusive “ideal” data package and reduce deficiencies during assessment, to reduce the number of ‘Notification With Grounds’ (NWG) letters generated.
We can now announce two separate symposiums, ‘Applying for a Marketing Autorisation – Advice from the Regulator on getting it right first time’ and ‘Variations Masterclass and Workshop’. Both have been crafted around feedback received from the November 2016 Abridged symposium (Minimising Deficiencies in new MAAs’).
‘Applying for a Marketing Autorisation – Advice from the Regulator on getting it right first time’, will be held on 29 and 30 November. A two-day event will allow us to focus heavily on content with the spotlight thrown on ‘minimising deficiencies in new MAAs’. Examples of subjects to be covered include case studies, CEP/ASMF, general deficiencies and how to avoid them, regulatory requirements for Drug Device Combinations, regulatory fundamentals for Bioequivalence/Biowaivers (quality/clinical) and a presentation on Well Established Use (WEU).
Prices will include a two day package with early bird tickets available, and for those who wish to attend only one or other of the days, day rate tickets will also be available (subject to availability).
The event will be held at a venue in Pimlico, a 15 minute walk from Victoria station and near to Pimlico underground station.
The ‘Variations Masterclass and Workshop’ is one single event and will be repeated 2 months later. The first is planned for 25 September, whilst the second event will be held on 24 November. To achieve a small, intimate, and interactive personal experience for the workshops, each event will be limited to a maximum of 48 delegates.
This second event will be held in-house (at MHRA's head office near Victoria), and will take the form of a presentation in the morning, covering Quality and Clinical variations, PIQU, Groupings, Worksharing and ‘Composite Coordinated Collections’, while the afternoon session will be based around two workshops each split into two syndicates (12 delegates per syndicate).
Tickets along with the pricing structure will be made available soon, including further details of the events and their respective agendas. Let us know in the comments if you'd like us to let you know when these details are published.