Presented by
Management Forum
Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course
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 (CTD)
2-3 October 2024 »
from £549
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
Course Overview
The Common Technical Document (CTD) Guideline is the obligatory format in the EU and most territories worldwide for registration applications. The clinical overview and clinical summaries in Module 2 provide a critical analysis of the clinical data within the CTD.
This interactive course will present the regulatory guidelines and requirements of Module 2 and discuss practical approaches to developing the content and preparation of the clinical overview and clinical summaries. The programme will provide a review of the latest information and potential future developments and cover associated documents, such as the RMP and SmPC. A practical workshop session will simulate real situations and highlight the key issues to consider when preparing the content of the written summary.
Benefits of attending:
- Gain practical advice on writing clinical documents for global submissions
- Review the latest guidance to ensure you meet regulatory expectations
- Understand how to prepare separate integrated summaries of efficacy and safety for FDA
- Clarify the content of orphan drug applications, over-the-counter (OTC) switches, line extensions and safety-related labelling updates
- Ensure your risk management plan (RMP) is consistent with the Common Technical Document (CTD)
- Discuss the place of the clinical overview and summary in life cycle knowledge from initial IB to PSUR, and how they support the changing summary of product characteristics (SmPC)
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Who should attend?
- Senior R&D managers
- Members of medical science clinical trial departments
- Medical writers
- Regulatory affairs personnel
- All those interested in the CTD document, clinical overview and summary and its place in the evolving clinical, safety and regulatory processes
The Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application course will cover:
The CTD Guideline
- CTD modules, structure and content
- An effective clinical overview
- The role of the written summary
- Agency validation
Planning content of the clinical overview
- Data sources
- Presenting efficacy and safety data
- Risk management
- Expressing benefit/risk
- Comparative effectiveness
- Avoiding pitfalls
Content of the written summary – practical considerations including a workshop
- 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
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, orphan drugs, over-the-counter switches, MA renewal, generic products and line extensions
- Recent developments and their effect on producing future CTDs
- The RMP and risk evaluation and mitigation strategy (REMS)
- Writing an overview and summary to support the SmPC and labelling changes
John Price
John Price Pharma Solutions
Dr John Price is a physician consultant in pharmacovigilance and regulatory affairs, working with several small biotechnology companies in North East USA planning submissions for marketing approval of oncology, haematology, renal and orphan drugs.
He was previously 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).
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
2-3 October 2024
Live online
13:30-17:15 UK (London) (UTC+01)
14:30-18:15 Paris (UTC+02)
08:30-12:15 New York (UTC-04)
Course code 13964
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 28 Aug
- 2 sessions of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
United Kingdom
- AbbVie Ltd
- AstraZeneca
- Callisto Pharma Group
- Cycle Pharmaceuticals Ltd
- Dermal Laboratories Ltd
- Drug Safety Solutions Ltd
- GW Pharmaceuticals Ltd
- Hameln Pharmaceuticals Ltd
- Ipsen
- Ipsen Biopharm Ltd
- JensonR+ Limited
- Kinesys consulting
- Martindale Pharm
- Martindale Pharma
- McDonough Clinical Research Ltd
- NDA Group
- NDA Regulatory Science Ltd
- Norgine
- Omega Pharma Ltd
- Orchard Therapeutics
- Pfizer Limited
- Pharmaceutical Company
- Reckitt Benckiser
- Scinopsis
- Scinopsis Ltd
- Teva UK Ltd.
- The Lewis David Consultancy Ltd
- Theramex
- United Therapeutics Europe Ltd
France
- chiesi
- GALDERMA Recherche & Developpement
- Guerbet
- Innate Pharma
- Ipsen Innovation S.A.S, Accounting Department
- LFB Biotechnologies
- Merck Sante s.a.s.
- Sanofi Aventis Recherche et Développement
- SERB SAS
Netherlands
- Astellas Pharma Europe BV.
- BBio
- Disphar International B.V
- Disphar International B.V.
- Eurodrug Laboratories B.V.
- Tiofarma BV
Switzerland
- Galapagos
- IBSA
- Idorsia Pharmaceuticals
- Mirum Pharmaceuticals Inc
- Novartis
- Novartis Consumer Health SA
Germany
- Bavarian Nordic
- Daiichi Sankyo Europe GmbH
- FARCO-Pharma
- Medac GmbH
- Trilogy Writing & Consulting GmbH
Belgium
- Emtex Life Science
- PhaRA BVBA
- Tigenix NV
- UCB Pharma SA
United States of America
- Alexion
- Ipsen Bioscience, Inc.
- Ipsen Bioscience, Inc. C/O Ipsen Biopharm Accounts Payable-Shared Financial Services
- Teva Pharmaceuticals
Italy
- Angelini ACRAF s.p.a.
- Philogen S.p.A.
- Zambon S.p.A.
Finland
- Medfiles Ltd.
- Orion Corporation
Poland
- Haleon
- Haleon Poland Sp. z o.o.
Portugal
- Owlpharma
- Owlpharma consulting
Croatia
- Belupo d.d.
Denmark
- Pharmacosmos A/S
Latvia
- Olainfarm AS
Mexico
- Laboratorios Silanes
Spain
- Dr. Victoria Howe
Sweden
- Camurus AB
Run Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Live online for your team
1 day
Typical duration
Pricing from:
- GBP 450
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
