Hardware Podcasts

#323 The Combination Products Handbook

Global Medical Device Podcast · 16 Jun 2023 · 42m · Episode 323

What this episode covers

Susan Neadle, principal consultant and president of Combination Products Consulting Services, discusses her peer-reviewed book, The Combination Products Handbook: A Practical Guide, published by CRC Press. Neadle explains how she collaborated with FDA officials, including John Barwiener, and industry experts from companies like Johnson & Johnson, Novartis, and Pfizer to create a consolidated resource for the complex niche of combination products. The episode details the book's structure, covering regulatory strategies, CGMPs, risk management, and human factors, while highlighting the challenges of harmonizing terminology between pharmaceutical and medical device sectors. Neadle emphasizes the importance of holistic thinking and integrated development to ensure patient safety and regulatory compliance across global jurisdictions.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, CRC Press, Johnson & Johnson, Unilever, Oregon Scientific, Janssen Pharmaceutical, FDA, ISPE, ASTM International, University of Maryland, Baltimore County, Sanofi, Novartis, Pfizer, Kamionox, Novo Nordisk, Janssen, Amgen, West Pharmaceutical, Lubrizol, AstraZeneca, XDA, Routledge, WHO, CDRH, CDE
Products
The Combination Products Handbook: A Practical Guide
Also
21 CFR Part 4, ICH Q9, ISO 14971, ASTM TIR 105, EU MDR

Related episodes from other shows

Other shows on the same ground, closest first.

  • Let's Combinate · 40m

    091 - Combination Products Handbook Part 1: Foundation, Learning from the process, Case Studies and Book Q&A with Susan Neadle

    Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and author of The Combination Products Handbook, joins host Subhi Saadeh to discuss the book's creation, structure, and key technical content. They explore the challenges of coordinating multiple global experts to create an 'evergreen' resource that addresses the complexities of combination products, including injectors and on-body devices. Neadle details specific regulatory strategies, such as the integration of ICH Q9 and ISO 14971 for risk management, and the nuances of CGMPs under US and EU frameworks. The conversation highlights case studies, human factors testing, and post-market surveillance best practices derived from industry experience and FDA collaboration.

    Medical & health devicesCertification & compliance
    10 chapters

  • Let's Combinate · 1h 23m

    022 - "What Chapter are you in?" with Susan Neadle

    Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and former Head of Combination Products at Amgen and Johnson & Johnson, discusses the regulatory and engineering challenges of combination products. She details the implementation of 21 CFR Part 4, the importance of harmonizing terminology between drug and device sectors, and her work with standards bodies like ASTM and AAMI on TIR 48 and TIR 105. Neadle explains her strategic planning frameworks, including the Merlin Exercise and Design to Value, to navigate complex quality systems and global regulatory differences.

    Certification & complianceLeadership, teams & culture
    8 chapters

  • Let's Combinate · 32m

    204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle

    Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and author of The Combination Products Handbook, explains the persistent regulatory confusion surrounding terminology in drug-device combination products. She details how terms like 'platform,' 'component,' and 'CAPA' are interpreted differently between pharmaceutical and medical device frameworks, creating significant compliance risks. The discussion highlights the failure of ASTM standards to align global definitions and emphasizes the need for a science- and risk-based approach to navigate these discrepancies.

    Certification & complianceMedical & health devices
    6 chapters

  • Let's Combinate · 35m

    045 - "Combination Products around the Globe" with Susan Neadle

    Susan Neadle, Principal Consultant at Combination Products Consulting Services LLC and former Head of Combination Products at Amgen, discusses the global regulatory landscape for combination products. She details the status of pending FDA guidances, including Essential Performance Requirements (EPRs) and post-market modifications, and explains the ASTM International standard for harmonizing terminology across jurisdictions. Neadle contrasts regulatory approaches in the US, EU, Canada, China, and other regions, highlighting differences in how products like pre-filled syringes are classified and reviewed.

    Certification & complianceMedical & health devices
    9 chapters

  • Let's Combinate · 40m

    152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh

    Subhi Saadeh, host of the Combinate Podcast and International Committee Chair for the Combination Products Coalition, joins Etienne Nichols to discuss the complexities of combination products. They define single-entity, co-packaged, and cross-labeled products, and explain the regulatory frameworks involving the FDA's CDRH, CDER, and CBER. Saadeh emphasizes that the primary mode of action determines the lead review office and highlights the importance of understanding QMSR updates and sterilization methods like VHP. The conversation also covers Saadeh's approach to podcast production, his use of coaching for career and fitness, and his recommendation of books like 'Quality is Free' and 'Bottle of Lies'.

    Medical & health devicesCertification & compliance
    8 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Global Medical Device Podcast. The episode itself belongs to its publisher.