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Seaport Hotel

2019 年 08 月 12 日 7:45 上午 - 2019 年 08 月 15 日 5:00 下午

One Seaport Lane, Boston, MA 02210

Regulatory Affairs: The IND, NDA, and Post-Marketing

Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.

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Session 13: Quality Assurance in Drug Development (GxPs)

Session Chair(s)

Drusilla Scott, PhD, RAC

Drusilla Scott, PhD, RAC

Vice President, Regulatory Affairs

Sobi, Inc., United States

  • Good Clinical Practices
    • Sponsor Responsibilities
    • Investigator Responsibilities
    • Institutional Review Boards
    • Informed Consent
  • Good Laboratory Practices
  • Good Manufacturing Practices

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