Application of ICH Q8 to Q11 in the development of outsourced CMC operations MasterClass - EU edition

In this course, we will learn of the modern regulatory paradigm of Science-based and Risk-based approaches to drug development (as reflected in ICH Q8 onwards), and of best practices to employ in order to fully harness the benefits of that approach, within fully outsourced and virtual operations.

03-04 June, 2024, Virtual
Time Zone: UTC/GMT+1 /CET

Overview

Manufacturing pharmaceuticals, especially biological products, is complex and expensive.

Many startup companies choose to outsource their manufacturing operations to a CDMO (Contract Development and Manufacturing Organization), to leverage on the CDMOs infrastructure and expertise, and avoid the business and technical risks associated with establishing in-house manufacturing capabilities.

Outsourced manufacturing is the perfect solution for early-phase products, where the clinical safety and efficacy are largely unknown. The hidden cost of outsourcing is the lost of knowledge and know-hows, which remains at the hands of the external partners. Moreover, in the absence of real infrastructure, startup companies can remain almost virtual, exposing them even further to the risks of lost knowledge.

In this course, we will learn of the modern regulatory paradigm of Science-based and Risk-based approaches to drug development (as reflected in ICH Q8 onwards), and of best practices to employ in order to fully harness the benefits of that approach, within fully outsourced and virtual operations.

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RECOMMENDATION

Who should attend?

• CMC Project managers (in startups and CDMOs)
• Quality Assurance (CMC)
• Manufacturing process development and MSAT teams
• CEOs and CSOs of small biotech startups
• Regulatory and CMC Consultants
• Business development at CDMOs