Webinar Duration: 90 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

With the increasing complexity of therapeutic agents -now involving more “biologics”-and an increase of use of new agents beyond the original intention and testing, it is essential to know as early as possible any untoward and unexpected Adverse Events and other serious toxicities. The well-known examples of Drugs pulled from the market after approval attests to the need for early surveillance. The adage of Forewarned is Forearmed clearly applies. Focus areas would be how you assure Investigator involvement, site protocol adherence, appropriate safety assessments, and methods for data sampling including internal audits.

Why should you Attend: There is a very real increase in the mandated frequency of real-time requests by the FDA for post-marketing surveillance and actual Phase IV trials and it seems that no one is well prepared. It is now reasonable to expect that the Sponsor’s should include Post-approval trials as part of the development of any new Investigational Medicinal Product (IMP). Investigators, as well as all site staff, must know how to assess Pre and Post market ADR’s as safety of the public is in the balance.

Areas Covered in the Session:
– What is “Pharmacovigilance”and why is it needed
– What are the types of studies: Phase I -Phase IV
– The Nature of the I/E criteria in the Phases of Drug Development
– How does the Safety Monitoring Plan differ in the Phases
– What constitutes a “rare”adverse event?
– Why large studies are needed to uncover rare Serious Adverse Events
– What is the role and value of a DMC in large studies
– What endpoints is the FDA looking for once they have approved a drug/device
– What agents have been pulled after approval and why

Learning Objectives:
– Identify the main differences between Pre-market and Post-market studies
– Contrast the elements of type II or ‘rare’ Adverse Events with type I Adverse Events
– Describe three AE mechanisms how an agent would be removed from the market after it had been approved

Who Will Benefit:
– Principal Investigators and Sub Investigators
– Clinical Research Scientists (PKs,Biostatisticians)
– Research Managers
– Safety Nurses
– Clinical Research Associates (CRAs) and Coordinators (CRCs)
– Recruiting Staff
– QA/QC Auditors and Staff
– Study Monitors & Clinical Research Data Managers

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).