Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application

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

13 Mar 2018

GBP 699
EUR 979
USD 1,090

Book now

Course Overview

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.

Why you should attend

Issues to be addressed during this meeting include:-

  • Meeting Regulators’ expections
  • Writing clinical documents for global submissions
  • Preparing separate integrated summaries of efficacy and safety for FDA
  • Content of generic applications, OTC switches and line extensions
  • Working with contract writing resource at home and abroad
  • Writing a Risk Management Plan that is consistent with the CTD
  • The place of the Clinical Overview and Summary in lifecycle knowledge from initial IB to PSUR, and how they support the changing SmPC

Who should attend

  • Senior R&D Managers
  • Members of Medical Science Clinical Trial Departments
  • Medical Writers
  • Regulatory Affairs personnel
  • All those interested in teh CTD Document
  • Clinical Overview and Summary and its place in the evolving clinical, safety and regulatory processes

Programme

09.00 Registration and Coffee
09.30 The Common Technical Document guideline

  • CTD modules, structure and content
  • An effective clinical overview
  • Sign-off
  • The role of the written summary

11.00 Refreshments

11.15 Planning content of the Clinical Overview

  • Data sources
  • Presenting efficacy and safety data
  • Risk Management
  • Expressing Benefit/Risk
  • Comparative Effectiveness
  • Avoiding Pitfalls
  • Issues with specific drug classes and therapeutic areas

13.00 Lunch

14.00 Practical considerations including a Workshop addressing:

  • The document writing process
    • Templates
    • Style
    • Timelines
    • Efficiency
  • The writing team
  • Engaging and working with external writers
  • Getting started, and reviewing and interpreting data
  • Document review: avoiding rework
  • Achieving Quality
  • Document Review and Approval

15.15 Refreshments

15.30 Meeting Regulators’ expectations

  • The CTD in a global company: regional and country requirements
  • Is a separate ISS or ISE necessary for an application to FDA?
  • Writing for NCEs, Mutual Recognition dossiers, Orphan Drugs, Over-The-Counter switches, MA renewal, generic products and Line Extensions
  • Recent developments and their effect on producing future CTDs
    • The risk management plan and REMS
  • Writing an Overview and Summary to support the SmPC and labelling changes

16.45 Discussion

17.00 End of meeting

Presenter

John Price

 Dr John Price is 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).

Book now

13 Mar 2018
13 Mar 2018 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • Astellas Pharma Europe BV.
  • AstraZeneca
  • Bavarian Nordic
  • LFB Biotechnologies
  • Mark Rippon
  • Martindale Pharm
  • Medac GmbH
  • Merck Sante s.a.s.
  • NDA Regulatory Science Ltd.
  • Novartis
  • Novartis Consumer Health SA
  • Omega Pharma Ltd
  • Orion Corporation
  • Pfizer Limited
  • TEVA UK LTD
  • Tigenix NV
  • Trilogy Writing & Consulting GmbH
  • UCB Pharma SA
  • United Therapeutics Europe Ltd
  • Zambon S.p.A.