In 2015, FDA changed the guidelines for Drug Master Files (DMFs). Beginning on May 5, 2017, all DMF submissions are required to be in electronic Common Technical Document (eCTD) format.
Join us on February 22 from 11am to 12pm EST when we will discuss the basic principles for DMFs and tips for preparing DMFs in eCTD format. We will also discuss how to convert existing paper DMFs to eCTD format. Sponsors and applicants can use this information to coordinate with manufacturers and vendors that use DMFs and determine the potential impact this transition will have on the applications.
A DMF is a regulatory submission to a health authority providing information about the drug that needs to be confidential. This information might include details of the manufacture of a drug substance, excipient or packaging material or a facility’s processes used in the manufacturing of a drug.
Who should attend:
- Pharmaceutical and biotechnology companies
- Companies that own a DMF or plan to submit a DMF (including amendments)
- Personnel in regulatory affairs, quality assurance, manufacturing, validation and research and development
Presenter
Beth L. Minter has been with the Regulatory Sciences group of Cardinal Health Specialty Solutions since 1999. She has more than 28 years of experience in the pharmaceutical industry, specializing in chemistry, manufacturing and controls (CMC), including quality control, regulatory affairs and compliance. Minter is responsible for scientific and regulatory consulting activities associated with pharmaceutical product development, development of regulatory affairs strategies, managing multidisciplinary drug development teams and preparation of investigational and marketing applications, including postapproval regulatory submissions.
Prior to joining Cardinal Health, Minter was the quality control manager for ChemSyn Science Laboratories, a specialty contract manufacturer for drug substances. Minter was responsible for development and validation of analytical methods for drug substances, as well as cleaning validation and release testing of raw materials, intermediates and drug substances. Minter currently serves on a United States Pharmacopeia (USP) Chemical Medicines Expert Committee.
To schedule a meeting and find out how we can help your organization create and implement a transition plan and provide post-implementation support, call us at 913.451.3955 or email us at regulatoryscience@cardinalhealth.com.