Regulatory Science, Quality Systems and Global Compliance

Regulatory science has become increasingly important in biotechnology innovation. Discussions include FDA, EMA and MHRA regulations, GMP, GLP, GCP, quality by design (QbD), regulatory strategy, risk management, and global product approvals. The session will examine evolving international regulatory frameworks that facilitate safe and efficient product development. Participants will gain practical knowledge on maintaining quality standards throughout the biotechnology product lifecycle.

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