This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document
19 Mar 2019
The Common Technical Document (CTD) Guideline is the obligatory format in the EU and most territories worldwide for registration applications.
This meeting will present the regulatory guidelines and requirements, discuss practical approaches to developing the content and preparation of the Clinical Overview and Clinical Summaries (module 2) and provide an update on the latest developments. Associated documents will also be discussed, such as the Risk Management Plan and Summary of Product Characteristics.
Issues to be addressed during this meeting include:-
09.00 Registration and Coffee
09.30 The Common Technical Document guideline
11.15 Planning content of the Clinical Overview
14.00 Practical considerations including a Workshop addressing:
15.30 Meeting Regulators’ expectations
17.00 End of meeting
Dr John Price is a physician consultant in pharmacovigilance and regulatory affairs, working with several small biotechnology copanies in North East USA planning submissions for marketing approval of oncology, haematology, renal and orphan drugs.
He was previosuly Vice President and Head of Global Pharmacovigilance and Drug Safety at Alexion Pharmaceuticals, USA. Until 2014 he was VP and Head of Medical, Clinical and Regulatory Operations at Johnson and Johnson Consumer Health, USA and previously VP of Medical Documentation, Labelling and Submissions Management, Worldwide Safety and Regulatory Operations, Pfizer Inc, USA. In these roles he has led and participated in the preparation of multiple clinical overviews and summaries for MAAs, variations, renewals and labelling updates globally.
He is a physician trained also in clinical pharmacology who has worked in the pharmaceutical industry since 1998, including working as a consultant providing medical writing support to pharmaceutical companies and service providers. Prior to joining Pfizer he spent 7 years as medical assessor and head of the Clinical Evaluation Unit of the Post Licensing Division at the Medicines Control Agency (now the Medicines and Healthcare products Regulatory Agency).