RECENT CONFERENCE PRESENTATIONS
July 16, 2019
RAPS Philadelphia Chapter: Reflections on EU MDR Article 117: Challenges and Opportunities from Pharma and MedTech Industry, West Chester, PA. Panelist
May 19, 2019
AAPS CMC Regulatory Exchange Forum: Combination Products: Bridging of Platform Delivery Devices, Drugs, and Their Changes. Somerville NJ. Invited speaker
April 9-11, 2019
4th FDA/PQRI Conference on Advancing Product Quality - Patient-Centric Product Design, Drug Development, and Manufacturing: Challenges with Drug Device Combination Products Post Approval: Challenges based on Differences in Global Regulatory Filing Requirements. Rockville, MD. Invited speaker https://pqri.org/wp-content/uploads/2019/04/3-2019-PQRI-FDA-4-Doug-Mead.pdf
March 26, 2019
PDA Chapter meeting: Combination Products Combination Product Hot Topics: Post Approval Device Changes and the New EU MDR Article 117 Requirements. Exton, PA. Invited speaker http://www.pdadelval.org/wp-content/uploads/2019/04/pda-west-present-combination-products-combination-product-hot-topics-post-approval-device-changes-and-the-new-eu-mdr-article-117-requirements.pdf
June 13, 2018
TOPRA Webinar: CMC SPIN Webinar & Q&A session: Pharma Combination Products: Hot topics in evolving US/EU regulations. Invited speaker
November 30, 2017
RAPS Workshop: Building the Scientific Bridge for Comparability of Combination Products. Rockville, MD. Organizer/Presenter
April 24-26, 2017
DIA CMC Workshop: Session chair and speaker: Session 04C Part 2; Clinical and Quality Considerations Applicable to Combination Product Bridging Principles. Rockville MD. Invited speaker
March 22-24, 2017
3rd FDA/PQRI Conference on Advancing Product Quality
TRACK #2 Achieving Drug Product Quality: Novel Approaches and Applications - Session 5. Drug/Device combination products: Regulatory perspectives on CQAs, CPPs, and Risk Analyses for Combination Products. Rockville, MD. Invited Speaker http://pqri.org/wp-content/uploads/2017/02/1-PQRI-TRAK-2-Sess-5-Combos-D-Mead.pdf
January 20-22, 2016
20th Annual Drug Delivery Partnership; Speaker/Attendee – Navigating the Regulatory Landscape for Combination Products; Regulatory requirements for drug delivery devices - and their impact on partnerships. Palm Beach, FL. Invited speaker
October 19, 2016
2016 PDA Drug Delivery – Combination Products Workshop – Speaker/Attendee - Device-Centric Studies for Combination Product Approval. Huntington Beach, CA. Invited speaker