sbiaevents.comsbiaevents.com/files/GCP2018-Agenda.pdf · FDA U.S. FOOD & DRUG ADMINISTRATION FDA &...

2

Transcript of sbiaevents.comsbiaevents.com/files/GCP2018-Agenda.pdf · FDA U.S. FOOD & DRUG ADMINISTRATION FDA &...

Page 1: sbiaevents.comsbiaevents.com/files/GCP2018-Agenda.pdf · FDA U.S. FOOD & DRUG ADMINISTRATION FDA & MHRA Good Clinical Practice Workshop: ata Integrity in Global Clinical Trials —
Page 2: sbiaevents.comsbiaevents.com/files/GCP2018-Agenda.pdf · FDA U.S. FOOD & DRUG ADMINISTRATION FDA & MHRA Good Clinical Practice Workshop: ata Integrity in Global Clinical Trials —

Clinical Perspective of FDA Approved Drugs With P ...

Clinical Perspective of FDA Approved Drugs With P ...

FDA Guidance_cGMP for Clinical Trials

FDA Guidance_cGMP for Clinical Trials

Pharmaceutical Guidelines_ISO, FDA, USFDA, ICH, WHO, GMP, MHRA guideline, Validation Protocol, SOPs_ GMP Audit Check List- Filling and Packaging.pdf

Pharmaceutical Guidelines_ISO, FDA, USFDA, ICH, WHO, GMP, MHRA guideline, Validation Protocol, SOPs_ GMP Audit Check List- Filling and Packaging.pdf

COVID-19 and Clinical Trials: The Medidata Perspective · 1 day ago · Switzerland swissmedic (v2.2 15Jun) Turkey TMMDA (31Mar) U.K. MHRA (21May) North America U.S. FDA (02Jul) Canada

COVID-19 and Clinical Trials: The Medidata Perspective · 1 day ago · Switzerland swissmedic (v2.2 15Jun) Turkey TMMDA (31Mar) U.K. MHRA (21May) North America U.S. FDA (02Jul) Canada

FDA Guidance for CMC for Clinical Trials

FDA Guidance for CMC for Clinical Trials

FDA 2013 Clinical Investigator Training Course: The Design of Clinical Trials

FDA 2013 Clinical Investigator Training Course: The Design of Clinical Trials

FDA Requirements for Clinical Trials and Market Approval

FDA Requirements for Clinical Trials and Market Approval

Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qserve Conference 2013)

Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qserve Conference 2013)

FDA Clinical Trial Requirements for Medical Devices

FDA Clinical Trial Requirements for Medical Devices

A Short History of FDA + Clinical Drug Trials

A Short History of FDA + Clinical Drug Trials

Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

Globalization of Drug Development - Boston University · Globalization of Drug Development : ... FDA : Globalization of Clinical Trials, 2001 . Source: FDA : ... 2013 Clinical trial.gov

FDA Compliance Actions Against IRBs and Clinical Investigators

FDA Compliance Actions Against IRBs and Clinical Investigators

An FDA Update on Clinical Trial Site Inspections: A View ...sitesolutionssummit.com/wp-content/uploads/2015/10/Podium_An-FDA... · An FDA Update on Clinical Trial Site Inspections:

An FDA Update on Clinical Trial Site Inspections: A View ...sitesolutionssummit.com/wp-content/uploads/2015/10/Podium_An-FDA... · An FDA Update on Clinical Trial Site Inspections:

Guidance for Clinical Investigators, Industry, and FDA Staff · PDF fileContains Nonbinding Recommendations Guidance for Clinical Investigators, Industry, and FDA Staff . Financial

Guidance for Clinical Investigators, Industry, and FDA Staff · PDF fileContains Nonbinding Recommendations Guidance for Clinical Investigators, Industry, and FDA Staff . Financial

Testing Computers Systems for FDA Mhra Compliance Computer Systems Val.ebooKOID

Testing Computers Systems for FDA Mhra Compliance Computer Systems Val.ebooKOID

Clinical Decision Support Software Proposed FDA Regulatory

Clinical Decision Support Software Proposed FDA Regulatory

Recent Developments in FDA Regulation of Clinical Trials

Recent Developments in FDA Regulation of Clinical Trials

FDA 2013 Clinical Investigator Training Course: Investigator Responsibilities-Regulation and Clinical Trials

FDA 2013 Clinical Investigator Training Course: Investigator Responsibilities-Regulation and Clinical Trials

FDA Decisions for Investigational Device Exemption ... · FDA Decisions for Investigational . Device Exemption Clinical Investigations Guidance for Sponsors, Clinical Investigators,

FDA Decisions for Investigational Device Exemption ... · FDA Decisions for Investigational . Device Exemption Clinical Investigations Guidance for Sponsors, Clinical Investigators,

Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA

Clinical Pharmacology Biopharmaceutics Review(s) - Accessdata FDA