DUBLIN--(BUSINESS WIRE)--The "The FDA (Food and Drug Administration) Drug Approval Process Training Course" conference has been added to ResearchAndMarkets.com's offering.
The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region. This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments.
The comprehensive programme will cover procedures for submission of INDs, NDAs, ANDAs and 505(b)(2), provide a useful insight into the organisation and structure of the FDA and its review processes, and highlight recent changes. The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs.
Who Should Attend:
This programme will be especially beneficial to those responsible for preparing US registration documents (INDs, NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market.
There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning.
Benefits of attending:
- Review the latest FDA regulatory requirements for drug development
- Understand FDA regulatory strategic needs
- Ensure that you comply with FDA requirements for NDAs, ANDAs and 505(b)(2)
- Discuss recent changes and developments with an industry expert and Improve your communication and interactions with the FDA
Key Topics Covered:
Day 1
Pharmaceutical Medicine and Documents
- The role of regulatory affairs
- The purpose of the Common Technical Document (CTD)
FDA History and Organisation
- Review of FDA centers
- Organization of the CDER and CBER
- Differences between CDER and CBER
Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA)
- 21st century cure act
- Patent and exclusivity
- PDUFA
- GDUFA
- BsUFA
Legal Basis Continued
Application and Submissions Types
- Investigational new drugs (IND)
- New drug applications (NDA)
- Abbreviated new drug applications (ANDA)
- Over the counter drugs (OTC)
- Biologics license applications (BLA)
- Orphan drug designations
Refusal to File
- Reasons for refusal
- The regulatory process
Investigational New Drug (IND) Applications
- Review of the content of an IND
Getting Products to the Market Faster
-
Review of expedited programs in the US
- Fast Track designation
- Breakthrough Therapy designation
- Accelerated Approval
- Priority Review designation
FDA Meetings and Documentation
- FDA communication philosophy
-
Different meeting types
- Scope
- Format
- Procedure
CTD Content - Setting the Scene
- Lean authoring to ensure possible document re-use for multiple purposes
- A review of the different modules
CTD Content - M1
Day 2
CTD Content - M3 and Corresponding M2
CTD Content - M4 and Corresponding M2
CTD Content - M5 and Corresponding M2
Submission Format and Methods
- Study tagging files
-
Datasets
- Case report forms
- Bioresearch monitoring (BIMO) clinical data
US Amendment Procedures
- A review of US amendment procedures (incl. annual reports, minor/major changes)
High Level Comparison US vs EU
- A review of the main differences in terms of dossier content and procedures
Case Study
Speakers:
Andrew Willis
Consultant
Independent
Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services. Catalent is the world's leading contract manufacturer and distributor of pharmaceuticals, and he was head of a team of internal and external regulatory affairs consultants. He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis.
He has 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He currently has a total of 28 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many Biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.
For more information about this conference visit https://www.researchandmarkets.com/r/ul1k89
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