Regulatory Hot Topics III

Introduction

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.
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.

The symposium will: Clarity regarding the rationale behind guidelines
Give practical advice on how to address challenges and realisation of the opportunities that exist.
Provide opportunities to challenge / raise concerns and understand from experts in the fields how they might be addressed.
Let you hear from experts what is actually happening in practice