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Course "Onsite GCP Review and Update including the all-important 'Investigators Responsibility'" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is known as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and, most importantly, that the safety, rights, integrity, and confidentiality of trial subjects is protected.
That all members of the team must know and practice "GCP" guarantees, that the Protocol is followed, that the Informed consent is complete, that the study conduct is according to the protocol, that Adverse Events are correctly recorded and that the Principal Investigator knows well her/his responsibilities to follow what "GCP" stands for
Why you should attend:
It is now reasonable to expect that the Sponsor's should become more discerning regarding the GCP qualifications and training of the staff of any unit conducting studies on human volunteers. Investigators, as well as all site staff, must know how to assess how well the unit is complying with the regulation and the essence of GCP to assure the safety of the volunteers as this ultimately affects the safety of the public. Following GCP is also an assurance of a clean audit.
Areas Covered in the Session:
Who will benefit:
This lecture series will provide invaluable assistance to industry study sponsors and those involved in Setting up the IND to follow the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (IMP) research involving human subjects. Those benefiting the most would be:
What is GCP and how does this concept improve data integrity and subject safety.The International Council on Harmonization leads the way
The Responsibilities of the Investigator and the relationship of the Investigator to the Sponsor and the IRB. The Regulations are quite clear in this regard. This includes the Informed Consent Process
In The Beginning: A solid Protocol; The basis of Drug Development starts with a medically sound Phase I Protocol, which defines Feasibility. Phase II and II Protocols must also be scientifically, medically, as well as ethically sound
How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant?
To conduct the Clinical Research study as if a person’s life depended on it - because it does
The Importance of Proper AE Determination and Reporting: How to handle AE's not in the Investigators brochure (IB) and properly assess the relationship between the AE and the product.
The Value of the Monitoring Process to an FDA Audit: including how a site or CRO prepares for an Audit and what the Auditors are finding.
The Importance of Standard Operating Procedures (SOPs) in the operation of a FDA form 483 absent CPU/CRU
Charles H Pierce, MD, PhD, FCP, CPI from an original Master's thesis (MSc in 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 28+ 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 actively involved in giving talks, 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).
Presently, he works part time in Urgent Care and is a 'waved' physician in The Addiction epidemic, Charles was an active squash player for 45 years, has been a committed Rotarian for 38 years, and a hobby photographer.
Location: San Diego, CA Date: January 18th & 19th, 2018 and Time: 9:00 AM to 4:00 PM
Venue: DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA
Price: $1,295.00 (Seminar Fee for One Delegate)
Register now and save $200. (Early Bird)
Until December 10, Early Bird Price: $1,295.00 From December 11 to January 16, Regular Price: $1,495.00
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Register for 10 attendees Price: $7,122.00
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Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
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