LIVE Online Course | 9am – 5pm CET
Navigate through the complex requirements of Module 3 of the Global CTD
Understand what data is required in module 3 and brainstorm common challenges and solutions for faster dossier submissions
The Quality and Pharmaceutical Module (Module 3) of the Common Technical Document (CTD) is a critical element of the submission process and must be navigated with the skill to minimise delays. This course will provide you with a clear understanding of the US and European regulatory requirements for Module 3 (CTD) of your application and will show you how to compile this important part of your submission dossier.
Through presentations and discussion sessions you will become confident at compiling the chemistry and pharmacy section of your dossier, ensuring your dossier contains all the relevant data needed. You will also develop skills enabling you to submit the Module 3 quickly, speeding up the overall submission and approval process.
Live Online Training Course
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions two days prior to the course start date. If you have any questions please contact firstname.lastname@example.org.
Build Module 3 (CTD) of the dossier to meet regulatory requirements
The legal framework
Understand the legal framework and guidelines for the CMC/Quality part of the dossier
Meet the legal responsibilities of the manufacturing authorisation holder, and the designated qualified person
Efficient submissions and approvals
Write variation submissions for Europe and get approval first time
Structure your submission teams to ensure compliance
Good Manufacturing Practice (GMP)
Link your dossier requirements to GMP
Certificate of Suitability (CEP)
Use certificate of suitability as replacement of data
Who is this course for?
This course has been specifically designed to address the needs of:
- Regulatory Affairs Managers/ Officers/ Assistants
- Compliance Managers
- Documentation Managers
- Product Registration Personnel
- Project Managers in Regulatory Affairs
- Qualified Persons
- Key contributors to the submission package
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age, or educational level. This course has been assessed and is CPD certified.
Very useful information and tips. The course was interesting and useful as we worked with specific topics/questions in groups.