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Regs and Guidance

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Implementing E6 R3:  IRT Systems, Part 1

Implementing E6 R3: IRT Systems, Part 1

Denise Lacey May 16th, 2025 7 minute read

Regs and Guidance

ICH GCP E6 R3:  Updates to Glossary

ICH GCP E6 R3: Updates to Glossary

Denise Lacey May 7th, 2025 4 minute read

Regs and Guidance

ICH GCP E6 R3:  Updates to Essential Records

ICH GCP E6 R3: Updates to Essential Records

Denise Lacey May 7th, 2025 3 minute read

Regs and Guidance

ICH GCP E6 R3: Updates to Investigator's Brochure

ICH GCP E6 R3: Updates to Investigator's Brochure

Denise Lacey April 9th, 2025 2 minute read

Regs and Guidance

Recap:  AgencyIQ FDA Webinar

Recap: AgencyIQ FDA Webinar

March 25th, 2025 5 minute read

Inspections | Regs and Guidance

ICH GCP E6 R3:  Updates to Data Governance Section

ICH GCP E6 R3: Updates to Data Governance Section

March 23rd, 2025 9 minute read

Regs and Guidance

ICH GCP E6 R3:  Updates to Sponsor Responsibilities - IMP

ICH GCP E6 R3: Updates to Sponsor Responsibilities - IMP

Denise Lacey March 17th, 2025 2 minute read

Regs and Guidance

ICH GCP E6 R3:  Updates to Sponsor Responsibilities - Safety Assessment and Reporting

ICH GCP E6 R3: Updates to Sponsor Responsibilities - Safety Assessment and Reporting

Denise Lacey March 17th, 2025 2 minute read

Regs and Guidance

ICH GCP E6 R3:  Updates to Sponsor Responsibilities - Noncompliance

ICH GCP E6 R3: Updates to Sponsor Responsibilities - Noncompliance

Denise Lacey March 16th, 2025 2 minute read

Regs and Guidance

ICH GCP E6 R3:  Updates to Investigator Responsibilities Section

ICH GCP E6 R3: Updates to Investigator Responsibilities Section

Denise Lacey February 20th, 2025 11 minute read

Regs and Guidance

ICH GCP E6 R3:  Updates to IRB/IEC Section

ICH GCP E6 R3: Updates to IRB/IEC Section

Denise Lacey February 20th, 2025 2 minute read

Regs and Guidance

Risk Management Book Club #3:  Thinking, Fast and Slow

Risk Management Book Club #3: Thinking, Fast and Slow

November 23rd, 2024 4 minute read

Regs and Guidance

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