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Drug Master File (DMF) and Drug Substance Workshop
March 3 & 4, 2021
7:30 a.m. – 4:30 p.m. (EST, UTC-4)

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This event is FREE

Via Webcast

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.

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Topics Include:

  • 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

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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
  • Compendia

Continuing Education Credit

This Forum:

  • 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.

Poster Presentations

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 Poster Presentations

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1. Timeline for the DMF review process (basic primer on how we align with ANDA)

Authors: Wei Song, Steve Kinsley. Alignment of the DMF review process with the ANDA review process and timelines will be covered.

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2. Completeness Assessments (CAs): Current CA Status, KASA for CA, Common Issues & GDUFA Commitment Letter Statistics

Authors: Yingzi Wang, Jayani R. Perera, Jason Crawford, Larisa Wu, and Xiang Yu. This poster discusses CA statistics, application of KASA, and advice for improving the CA outcome.

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3. Metrics on DMF Assessments

Authors: Steve Kinsley, Wei Song. DMF statistics including adherence to due dates and overall productivity will be presented.

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4. Introduction to FDA Drug Master File Form 3938

Authors: Vathsala Selvam and CDR David Skanchy. The new FDA DMF form 3938, similar to the application 356h form, will be presented.

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5. Cocrystal APIs: Recommended Documentation

Authors: Weiqin Jiang, Neeru Takiar, and Ramnarayan Randad. A discussion of API sameness with regard to cocrystal APIs will be covered.

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6. Synthetic Therapeutic Polymers: Recommended documentation for API sameness

Authors: Bapu R. Gaddam, Ramnarayan Randad, Benjamin Lim, David Skanchy. Regulatory strategies to establish API sameness of cross coupled polymers.

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7. Synthetic Therapeutic Peptide APIs: Recommended documentation for API sameness & related impurities

Authors: Suresh Jayasekara, Manivannan Ethirajan, David Green, and Ramnarayan Randad. Practical advice on achieving API sameness in peptide drug substances is provided.

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8. Regulatory Considerations for Synthetic and Semi-synthetic Oligosaccharide Complex APIs in Generic Products

Authors: Keduo Qian, Barbara Scott, Govindaraj Kumaran, Weixiang Dai, CDR David Skanchy. We will present the Agency’s current thinking on the active ingredient sameness assessment of oligosaccharide complex APIs in generic and reference products.

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9. Quality Considerations for Continuous Manufacturing of APIs

Authors: Anjali Bain, Yun J. Wang, Ramnarayan Randad, David Skanchy, Adil Mohammad, Raymond Frankewich, and Thomas O’Connor. This poster is based on the draft guidance Quality Considerations for Continuous Manufacturing and provides information regarding FDA’s current thinking on the quality considerations for continuous manufacturing of small molecule drug substances.

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10. ANDA Aligned Teams

Authors: Steve Kinsley, Wei Song. The new Integrated Quality Assessment (IQA) alignment of teams to facility collaborative review will be presented.

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11. Review of Secondary Type II Drug Master Files

Authors: Madhusudhan Gowravaram & David Skanchy. This poster will discuss the risk-based review approach for the acceptance of secondary DMFs for the adequacy of primary DMFs supporting A/NDAs and some regulatory aspects of secondary DMFs.

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12. USP Pending Monograph Process and USP compliance for Industry

Authors: Yan Ma, Yun J. Wang, Anita Tiwari, Barbara Scott. This poster provides information on FDA’s current thinking on the USP-PMP and recommendations for drug master file (DMF) holders.

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13. Evaluation of Metal Impurities in Drug Substances

Authors: Donglei Yu, Mst Hasina Akter, Wei Liu, Ramnarayan Randad. The risk assessment for elemental impurities in drug substances and atypical drug substances will be discussed.

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14. Mutagenic Impurities from a Drug Substance Perspective: Highlights from the ICH M7 Question and Answer Draft Document

Authors: David Green, Barbara Scott, CDR David Skanchy. We will highlight four topics covered in the new ICH M7 Question and Answer Draft Document surrounding the control of mutagenic impurities.

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15. Establishing Impurity Acceptance Criteria as Part of Specifications for DMFs Based on Clinical Relevance

Authors: Yongjun Gao, Ramnarayan Randad, David Green, Weixiang Dai, Hongbiao Liao and David Skanchy. Advice on establishing impurity limits in various cases is provided.

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16. API Manufacturing Global Distribution and Facility Profile Analysis

Authors: Wei Song, Ying Zhang, Nathan Chen, and CDR David Skanchy. We will discuss the diverse and complex global API supply chain.

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17. Communications with DMF Holders and Applicants throughout the DMF Lifecycle

Authors: Fatima C. Sequeira, Vathsala Selvam, Claude Theophin, Terrence Nichols, Ben Danso, David Skanchy. We will review available pathways, that DMF holders and applicants can communicate with Agency.

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18. The DMF Teleconference Process

Authors: Benjamin Danso and Jayani Perera. The current process for requesting, granting, and executing a DMF teleconference will be described along with data and metrics for the process from GDUFA I to present.

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19. List of Relevant Quality Guidances & Common Deficiencies Observed during Drug Master File Review

Authors: Sad Ahamed and Mahmut Levent. This poster provides a non-exhaustive list of relevant technical guidance applicable to DMFs and discuss common deficiencies.

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Agenda & Speaker Bios

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Event Agenda

The agenda may be updated as changes to the schedule occur. The currents version is Version 4, updated on January 8, 2021.

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Speaker Biographies

The speaker biographies document is being finalized and will be posted here as soon as it is ready.

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Virtual Attendance Information

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.

Last Name A – K

Last Name L – Z

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:

https://concerted.adobeconnect.com/common/help/en/support/meeting_test.htm

Files, Certificate & Recordings

ZIP of Day One Session Slides

ZIP of Day Two Session Slides

The ZIP files above will be available for download 24 hours before the event.

Link to Final Evaluation & Certificate of Attendance

The above link will become active at the conclusion of the event.

Session Recordings:

Links to recordings will be added as they become available.

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Questions & More Information

Questions?

Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.

More Information

If you have questions regarding the content of the event or other CDER-specific information, please: