Key Implications for Regulatory Professionals & Their Role as Business Partners
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Chemistry, Manufacturing and Controls (CMC or Quality) is one of the three key areas (with Safety and Efficacy) that health authorities (HAs) consider for the review and approval of drug applications. Effective CMC strategies and execution may reduce regulatory burden, enable shorter review timelines, and support postapproval maintenance. This program will convey key CMC concepts, challenges and opportunities encountered by those working in regulatory strategy as well as to those in functional areas who partner with regulatory to achieve business goals.
In addition to demonstrating technical proficiency related to CMC, regulatory professionals must also cultivate strong partnerships with internal and external functional areas in order to achieve their strategic and tactical goals. These partnering functional areas, including business development, operations, product development and product life cycle management, play an integral role in product development. Regulatory's ability to understand how these functional areas' activities interact with and support CMC can have a considerable impact on an organization's ability to successfully launch a new drug.
Primary areas of focus for this program include (1) knowledge and execution, (2) enabling business objectives and (3) pressing technical issues. Hot topics will be addressed by experts in the field to provide critical details and key take-aways. A partial listing of the topics follows.
Knowledge and Execution
- Winning strategies for presenting CMC data and information to HAs
- CMC initiatives for biotech and specialty pharma
- Biologics CMC for a global environment
- Combination (drug/device) products: Challenges for timely submission, review, and approval
- Strategies for postapproval changes and dossier control
- eCTD: how emerging HA requirements will drive your pre- and post-approval document publishing and archival systems
Business
- Offshoring: An increasing strategy for network rationalization and emerging firms: Pros and cons, and the role for CMC
- Outsourcing: How emerging firms and startups can outsource development and commercial activities to drive timelines, overcome resource constraints, and improve efficiencies
- Mergers and Acquisitions: Considerations, challenges, and opportunities for the regulatory professional
Technical
- Quality by Design: The coming expectation for development, registration, and life cycle improvements
- Continuous manufacturing: Considerations for submission
- Process Analytical Technologies (PAT) regulatory challenges and opportunities for in-process controls and Real Time Release testing
- Genotoxic impurities: An emerging area of regulatory scrutiny for development and registration for small molecules
This workshop will provide participants with opportunities to query the speakers, share experiences to promote mutual development, and engage with new colleagues for professional growth.
Learning Objectives
At the conclusion of this meeting, participants should be able to:
- Describe key concepts in the business, technical, and execution applications of regulatory CMC
- Demonstrate process understanding, risk assessment, and quality systems
- Understand the importance and emerging trends in electronic submissions and document maintenance
- Translate the development of product knowledge into effective regulatory submission content
- Communicate to company stakeholders the benefits and risks associated with a particular regulatory CMC strategy
- Enhance their organization's current strategies for successful technical-regulatory filings
Target Audience
This program will benefit early, mid- and senior level regulatory professionals in CMC working in development, registration, and post-approval.