Good Clinical Practices 2015 - Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements

Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements
This GCP training course is designed to provide participants with an in-depth understanding of the clinical research process, the roles and responsibilities of key players, as well as, regulatory requirements.
Why Should You Attend:
Upon completion of this course, each participant will have a thorough understanding of the latest updated GCP requirements dictated by FDA, European regulators and ICH requirements for sponsors, monitors, and investigators.
In addition, the significance of these regulations will be correlated to protocol and case report form development for all phases of clinical research. Information regarding in-field and in-house auditing (i.e., quality assurance (QA) procedures compared to FDA’s bio-monitoring system) will be presented. Investigational Review Boards (IRBs) and Informed Consent (IC) as required by the FDA and ICH regulations will be discussed and compared with GCP and ICH regulations.
This webinar will provide attendees with the training needed to improve clinical trials and ensure compliance with Good Clinical Practices, FDA regulations, EU directives and ICH guidelines. The differences in study initiation and conduct between the US, EU, India, China and Japan will also be discussed.
Areas Covered in the Webinar:
? How drugs are discovered and developed for marketing approval
? The four different study phases of clinical research
? What constitutes Good Clinical Practices (GCP)
? How the requirements differ in the US, EU, India, China and Japan
? The principles of ICH GCP
? The IRB/IEC’s composition and role/responsibilities
? The IRB study review and approval process
? The role and responsibilities of the investigator and study site staff
? The role and responsibilities of the sponsor
? The history of the FDA and EMA and their role and responsibilities
? Which sections of 21 CFR and ICH guidelines govern conduct of clinical studies
? The purpose for an IND/CTA and its composition
? How INDs and CTAs are filed, reviewed, approved and amended
? The IND/CTA reporting requirements
? The requirements for Informed Consent
? How to review an Informed Consent form for compliance
? The process for Informed Consent review and approval
? The administration of subjects Informed Consent
? How to perform drug accountability and compliance
? How to manage study supplies
? The purpose and composition of the NDA/MAA
? How NDAs/MAAs are filed, reviewed and approved
? Sponsor responsibilities after approval
? How to review study documents and determine compliance
? How to review case report forms and determine adherence to protocol
Who Will Benefit:
This GCP training webinar is specifically designed for clinical operations staff as well as GCP auditors and others involved in conducting clinical studies of new medications who require a working knowledge of the regulatory requirements (US and EU) and ICH regulations for Good Clinical Practices (GCPs).
Clinical research managers who oversee and instruct CRMs and CRAs will gain insight into how to best train these employees and how this information can help provide more consistent compliance of the GCP requirements. Other research professionals will also benefit from this GCP training program.
The course will benefit:
? Study Managers
? Medical and Study Monitors
? GCP Auditors
? Clinical Research Managers
? Clinical Investigators
? Research Coordinators
? Regulatory and Medical Communications Personnel
Instructor Profile:
Upon earning a degree in Zoology at North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. McElroy moved to Wyeth Lederle and worked in quality assurance, performing GMP compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in quality assurance for a few years, she moved into equipment qualification and cleaning validation at Mallinckrodt.
With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
In 2013, Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.
Contact for Registration:
http://www.complianceonline.com/good-clinical-prac...