6th Annual Global Regulatory Affairs CMC: Chemistry Manufacturing and Controls Conference

Obtaining Positive Regulatory Approval of CMC Submission Dossiers through a Comprehensive Understanding of Global Submission Requirements, Thorough Postmarket Change Control Processes, and the Employment of Lifecycle Management Strategies

As pharmaceutical and biotechnology therapies continually become more complex, CMC executives are continually challenged to ensure the product’s chemical makeup, overall quality, and efficacy are showcased through strong evidentiary support. Since these hurdles are faced throughout the product’s lifecycle, it is critical for CMC teams to remain hands-on with the product as it evolves while on the market.

This lifecycle of CMC operations is complicated by continual guideline changes and lack of global regulatory harmonization. Through gained insight of current regulations and technical data and documentation requirements, CMC executives will be better equipped to ensure streamlined approval processes and uninterrupted product supply chains.

The 6th Annual program will virtually connect industry experts and address a range of topics from CMC data requirements and regulations from different global marketplaces, streamlined approaches to combination product CMC and global tracking tools to monitor CMC practices and approval statuses.

Learning will be delivered in three half day modules to maximize learning and engagement. Individual modules are available for $595. The entire course may be accessed for $1,500.

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A Special Thanks to Our Sponsors:

Halloran is a life science regulatory, quality and clinical consulting firm that provides deep and broad domain expertise tailored to each client relationship. Our team is a trusted partner with subject matter experts, proven by our track record across a long-standing and diverse client base. Halloran’s highly experienced team delivers a flexible and integrated partnership approach that successfully propels clients to their next inflection point. In working with one of the most expansive and relevant clinical pipelines in the industry, Halloran empowers its clients to optimize their organizations and achieve their next development milestone.

Kinapse as a Syneos Health^® company is a leading global regulatory services provider that helps clients gain significant business advantages, efficiencies and cost-savings that go beyond traditional benefits.  Our CMC strategic and operational support covers: 

o   Annual reports and licence renewals
o   CMC variations (including change control)
o   MAH transfers and Legal Entity Name Changes
o   Complex manufacturing site transfers including API and sterile products
o   Conformance assessments
o   Compliance and dossier remediation 

Our SMEs provide consultancy and operational services across the full product lifecycle from Phase 1 through Loss of Exclusivity and beyond to support the ‘Lab to Life’ ® continuum.