Drug Master File (DMF) and Drug Substance Workshop
March 3 & 4, 2021
7:30 a.m. – 4:30 p.m. (EST, UTC-4)
This event is FREE
Ensuring high quality and manufacturing integrity of Active Pharmaceutical Ingredients (APIs) requires understanding and incorporation of quality and risk management principals throughout the API lifecycle. This conference is designed to provide an update on current Agency initiatives and will cover a wide variety of topics of interest to API manufacturers and regulators. Specifically, the Agency wishes to provide guidance on the DMF submission process and expectations for content through a series of presentations, panel discussions, and Q&A for two poster sessions. The desired outcome is to outline the various regulatory steps necessary for the successful development of a high-quality submission of drug substance information to the Agency.
- Information on submitting and managing DMFs, fee payments, and facility identification
- How to maximize communication tools offered by the agency to get answers to your questions
- What to consider for development of a complex API
- Process validation and ICH Q7
- How to select an appropriate regulatory starting material (ICH Q11 and Q11 Q&A)
- Expectations for impurity assessment ((Q)SAR & pharm-tox) and control (ICH Q3A, Q3C, Q3D, and M7)
- How to develop a robust chromatographic method for API release
- Expectations for Lifecycle Management of DMFs and the Draft Post-Approval Change Guidance
- Common mistakes and how to avoid them: Case study examples
- Posters covering topics of interest
Who Should Attend?
- Manufacturers of active pharmaceutical ingredients in support of an ANDA or NDA (AAM, APIC, PhRMA, EFPAI, JPMA, DIA)
- Regulatory Affairs Professional or Agents
- Outside testing facilities that provide data to support the safety (AMES Studies, (Q)SAR predictions, nitrosamine testing to support risk assessment) or quality (release or stability testers) of the active pharmaceutical ingredient in a DMF
- Outside manufacturing facilities that provide intermediates to be used in the manufacture of active pharmaceutical ingredients.
- Foreign Regulatory Bodies
Continuing Education Credit
- has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
- has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.
- has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- has been approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
- Continuing education certificates are available only for those who attend real-time. There is a three week deadline to obtain the certificate of attendance and complete the event survey.
In addition to the presentations during the 2-day Conference, there are 19 pre-recorded Poster Presentations on a variety of topics. You are invited to view the poster presentations and submit questions for any of them. Questions must be submitted by February 15, 2021. The questions will be reviewed and addressed during the “Poster Presentations: Responses to Submitted Questions” sessions during the Conference.
The links to the presentation videos and to submit questions will be added to the list below as soon as the videos are ready.
The agenda may be updated as changes to the schedule occur. The currents version is Version 4, updated on January 8, 2021.
The speaker biographies document is being finalized and will be posted here as soon as it is ready.
The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 each in Room One and Room Two). If a room is full when you attempt to enter, please try the other room. The recordings of each of the sessions will be posted below within 24 hours.
The links below to the Adobe Connect rooms will be activated shortly before the event begins.
Please select the correct room based on the first letter of your LAST NAME.
The above rooms will open ~15 minutes before each day begins.
If you encounter any technical issues, visit the Technical Issues Support Page
The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.
To test your PC, please visit:
The ZIP files above will be available for download 24 hours before the event.
The above link will become active at the conclusion of the event.
Links to recordings will be added as they become available.
If you have questions regarding the content of the event or other CDER-specific information, please: