Attaining Positive Regulatory Response to CMC Submission Materials through Thorough Knowledge of Global Core Dossier Development, Strategies for Swift Post Approval Submission Acceptance, & Compliance Best Practices for ICH Q12 Lifecycle Management
As pharmaceutical and biotechnology therapies continually become more complex in compound makeup and product design, CMC executives concurrently struggle to ensure strong evidentiary support regarding the safety and efficacy of the product’s chemistry. The challenges faced by CMC executives are not solely encountered during the drug discovery phase of a product but through the product’s entire lifecycle and it is essential for CMC executives to remain hands-on with all aspects of the product as it evolves while on the market. This life span of CMC operations is furthermore complicated by the continued guideline changes and lack of global regulatory harmonization. Through gained insight regarding current regulations along with technical data and documentation requirements, CMC executives will be better equipped to ensure streamlined approval processes and uninterrupted product supply chains.
Building on conference knowledge share and success of previous conferences, the 2017 program will showcase industry experts within CMC operations, who as presenters will share experiences and knowledge that will be of great benefit to all attending delegates. Industry leaders will address a range of topics from highlighting CMC data requirements and regulations from different global marketplaces, ICH Q12 life cycle management considerations, strategies for streamline accelerated pathway CMC activities, and ICH Q3D guidelines for elemental impurity testing. Through case study driven presentations, as well as interactive panel discussions complemented by multiple networking opportunities, the program will foster a sense of collaboration and promises to be a valuable program to those who are looking to enhance managed market operations.
Lydia Welmer | Marketing Coordinator | Q1 Productions
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