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1
SCCE's December ESG and Compliance Conference
01 Dec 2022 • Virtual, United States
Organizer:
Health Care Compliance Association (HCCA)
Abstract:
Environment, Social, and Governance (ESG) is no longer an isolated function within a company, nor is it an issue only for publicly traded companies. It’s front and center for organizations of all types and sizes, and it requires the involvement of the compliance team in order to be properly addressed. Much like regulatory risks, managing ESG goals and metrics requires a collaborative effort across multiple units within an organization.

Join us on December 1, 2022 for ESG and Compliance. This virtual conference, led by ESG and compliance professionals, addresses the current state of ESG and the importance of collaboration among ESG, compliance, and other functions within an organization.

Event listing ID:
1466372
2
FDA’s GMP Expectations for Phase I — FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
08 Dec 2022 - 09 Dec 2022 • Washington DC, United States
Organizer:
FDAMap
Abstract:
Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements. The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.
Topics:
Clinical Trials Clinical Studies Clinical Research GMP FDA Regulation FDA Compliance
Event listing ID:
1506303


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Last updated: 5 September 2022