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.
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
Certifications:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
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 Submission 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
Hans van Bruggen,
QdossierHans van Bruggen is CEO of and Senior Regulatory Affairs Scientist at Qdossier. He holds an MSc. in Pharmaceutical Medicine from the University of Surrey (UK) and has worked in the pharmaceutical industry for more than 35 years, primarily at global or European headquarters sites. He has gained a wealth of experience and a comprehensive view on what information is needed to evaluate the benefit/risk ratio of drugs for patients and healthy volunteers. He approaches interdisciplinary and international processes using that scientific background. He applies new technologies and Artificial Intelligence to facilitate the business and let people focus on what they can do best.
Ms Marloes van der Geer,
Senior Regulatory Affairs Scientist ,
QdossierMarloes van der Geer works as senior regulatory affairs scientist at Qdossier. Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier. Marloes’ areas of expertise are: eCTD, lean authoring, publishing, biopharmaceuticals (incl. biosimilars), clinical development, regulatory convergence & harmonization and facilitated registration pathways (incl. orphan drugs), local RA activities (e.g. product information management).
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.
