Principal Investigator Responsibilities in Clinical Research GCP 2018

Principal Investigator Responsibilities in Clinical Research GCP is organized by GlobalCompliancePanel and will be held during Jan 18 - 19, 2018 at DoubleTree By Hilton Hotel San Diego Downtown, San Diego, California, United States Of America.

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:
"Principal Investigator Responsibilities in Clinical Research GCP 2018'" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:
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 Good Clinical Practices.

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.

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.

• The Study Sponsor
• 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:
Charles H. Pierce
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.

Prices:
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
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar