Regulatory

Content highlights regulations and guidance issued by international regulatory bodies and coalitions. Case studies could demonstrate the application of regulations and industry-generated guidance for global harmonization of compliance and product registration. Topics could include regulations, standards, practices, and guidance related to drugs, the environment, health, and safety.

Initiatives

Current Topics

Accelerated Development & ManufacturingAnalytical Method Strategy / ICH Q2(R2), Q14Continuous ManufacturingICH Q9(R1)
ICH Q12 ImplementationPatient Centric Quality StandardsProcess ValidationTransportable/POC Manufacturing

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