Final FDA Guidance : Form FDA 1572 - Recorded Webinar

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Charles H Pierce

OVERVIEW:
When the PI signs the FDA form 1572 (for IND studies) or the "Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations.

In the FDA form 1572, the Investigator signs an agreement that has 9 statements, 7 of which begin with "I agree". Named in the 1572 is 21 CFR 50 (Protection of Human Subjects), 21 CFR 56 (Institutional Review Boards), and 21 CFR 312 (Investigational New Drug Application / IND). For Device studies, 21 CFR 812 (Investigational Device Exemptions / IDE) is added in place of 21 CFR 312. Additional responsibilities are clearly outlined in The GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811. To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know and follow these regulations is folly.

Areas Covered in the Session:
- The Investigators role in the clinical research process
- The difference between AEs and SAEs and the reporting requirements of the investigator
- Why the investigator maintains a list of staff signatures?
- Why the investigator files the signed and dated protocol?
- Why the investigator is responsible for the IC process?
- What is the legal language of the FDA form 1572 or Device equivalent?
- Why is Financial Disclosure information important?
- What is the history of the drug / device regulations?

Who will Benefit: This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects.

Those benefiting the most would be:
- Principal Investigators and Sub Investigators
- Clinical Research Scientists (PKs, Biostatisticians)
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting Staff
- QA / QC Auditors and Staff
- Clinical Research Data Managers

SPEAKER PROFILE:
Charles H. Pierce MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 48+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 27+ years in the medical research industry (7 years as a Principal Investigator), Charles has an experienced based knowledge of the Clinical Research part of Drug Development.

He is an APPI/APCR Certified Principal Investigator (CPI in 2003 and recertification’s to 2018). He is frequently actively involved in Webinars, courses and workshops giving the clinical investigator and staff an understanding and appreciation of the ethics as well as the science and regulations governing clinical research with drugs or devices. The end must be knowledge and keen observation to ensure drug safety. Charles’ active management experience in the medical research industry gives him first-hand practical experience and knowledge to develop Phase I, IIa confined study Clinical Pharmacology Units (CPU’s). From experience and practical know-how the special needs of these units (from the floor plans to operational SOPs) has been of added value to those considering this venture. He has work experience in Device Studies and Pharmacovigilance. The later (PV) is of special interest as Phase I through Phase III do not guarantee drug safety. Actually this vigilance must start with the very first studies in human subjects.

Charles is a Fellow and Life Member of the American Academy of Family Physicians and Emeritus fellow of the American College of Clinical Pharmacology (ACCP) of which he was a Regent 1995-2000, Chairman of the 2001 annual meeting, and the 2004 recipient of the Nathaniel Kwitt Distinguished Service Award. He is an active member of the Association of Clinical Pharmacology Units (ACPU) of which he was a trustee (2007-2011) and chaired the successful 2010 annual meeting. He is also a member of the Academy of Physicians in Clinical Research (APCR) and the 2012 Chair of the Board to trustees of the Academy of the Association of Clinical Research Professionals (ACRP).

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