JPAG - PAST MEETINGS
Thursday 1st December 2016
Regulatory Hot Topics II
Royal Society of Chemistry, London
Purpose of the symposium To address issues and challenges associated with the implementation of new and emerging guidelines
Challenges The advent of any new guidelines brings challenges. No matter how clear and definitive any guideline is, it typically only provides a framework. A framework that applicants and regulators alike need to firstly understand and then interpret and translate into actual practice. This transformation from principles, however helpful, to established practice can be difficult and can result, at least initially, in divergence. It is only though dialogue and the opportunity to discuss through effective forums such as this symposium that this process can be streamlined.
Opportunities Guidelines are designed to address issues and through addressing issues provide opportunities to significantly enhance effectiveness. This effectiveness relates to all, applicant and regulator. This opportunity though can only be realised if there is mutual understanding of the challenges and collaboration in addressing them. This symposium seeks to bring together experts in the areas covered by the new and emerging guidelines to provide that exact opportunity.
Clarity regarding the rationale behind guidelines
Practical advice on how to address challenges and realisation of the opportunities that exist.
Opportunities to challenge / raise concerns and understand from experts in the fields how they might be addressed.
Hear from experts what is actually happening in practice
Topics will include
ICH Q3D: reflection on impact six months after implementation
ICH Q12; current status of the guideline
Continuous manufacture; reflections on the current status and regulatory acceptance
Excipient GMP; status and compliance
Analytical methods; allowable flexibility
Perspective on the challenges of development and filing of a breakthrough status medicine
Microbiological quality of non-sterile dosage forms (USP 1111 and 1115)
Registration starts at 9.30 and the symposium starts at 10.00
Dr Gurjit Bajwa - GlaxoSmithKline
Paul Butterworth - AstraZeneca
Dr Graham Cook - Pfizer
Dr David Elder - JPAG/Consultant
Ewan Norton - MHRA
Dr Stephen Smith - AstraZeneca
Dr Andrew Teasdale - AstraZeneca
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Delegates at a symposium held at the Royal Pharmaceutical Society