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 Covered: 

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 

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) 

Target Audience 
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 
Language: English | Handout: English
Speaker: Carlos Martinez

For whole teams we offer attractive special prices with special advantages or develop your own in-house training for you - please contact us.

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