EU vs. US Dossiers for Generic Product Applications: Mastering CMC and Module 1 Differences (11008)

While the CTD format provides a harmonised framework, substantial differences remain in how regulatory authorities in the EU and US interpret and assess Modules 1 and 3. These differences can result in delays, rejections or additional data requests in generic product applications. This 90-minute webinar focuses on the most critical regulatory divergences in the CMC sections and regional administrative requirements, helping participants align submissions and avoid costly pitfalls. 

Topics: 

• Dossier Module 1 – Key Regional Administrative Requirements: 
  • Master File Strategies (CEP, DMF, ASMF) 
  • GMP Declaration and Site Certification 
  • Product Information & Labelling Requirements 
  • Administrative and Application Forms 
• Dossier Module 3 – Quality (CMC) Differences in: 
  • Drug Substance (3.2.S): Manufacture (3.2.S.2), Characterization (3.2.S.3), Control of Drug Substance (3.2.S.4), Stability (3.2.S.7) 
  • Drug Product (3.2.P): Formulation (3.2.P.1), Manufacturing Process (3.2.P.3), Control of Excipients (3.2.P.4), Specifications & Analytical Methods (3.2.P.5), 3.2.P.7 (Container Closure System), Stability Data (3.2.P.8) 

Who should attend?
This webinar is intended for professionals working in:

• Regulatory affairs (all seniority levels) 
• CMC dossier writing and preparation 
• Quality assurance and GMP compliance 
• Regulatory consultants managing submissions in the EU and/or US market 

Duration: approx. 90 minutes 
Presentation language: English
Speaker: Carlos Martinez

Especially for groups - Your benefits at a glance

• Attractive special prices or discounts for entire teams or small groups.
• On request, we offer customised inhouse-packages that are perfectly tailored to the needs of your department or company.
• Book Streaming+ option: Take advantage of our flexible Streaming+ format, which also allows you to have an interactive live Q&A session with the speaker to clarify your questions directly with the expert.

Feel free to contact us by email at info@alphatopics.de or by phone - we look forward to your enquiry.

Note on contingent call-off: When booking this webinar described here, one unit will be deducted per participant.