- OVERVIEW AND WHY SHOULD YOU ATTEND
- AREAS COVERED AND LEARNING OBJECTIVES
- WHO WILL BENEFIT
With the increasing frequency of real-time FDA audits and complexity of Investigational Medicinal Products (IMP’s), the wise are paying more attention to including a full range of lab tests to insure IMP safety.
Which lab values outside of the Reference range are to be reported as AE’s is always a question that must be answered and will be reviewed. The question of the relationship of lab data to “FDA Adverse Event reporting system” determination is the decision of the Investigator guided by what is in the protocol.
The section on “Safety monitoring systems” includes the array of lab tests taken at prescribed intervals adjudged to answer the safety questions. Whereas evaluation of this safety data is the Investigators responsibility, it is essential for the whole team and the sponsor to be on board with the timing and extent of this testing.
The source of lab data is also important, as for the data to be interpretable it must be accurate, reliable and repeatable. For this reason the choice of a lab following the principles of “GLP” (21 CFR 58) or, better, certified in “GCLP” is a goal to be obtained.
why should you attend
Unless you have extensive experience in lab data interpretation including cardiac monitoring, an overview of how best to view safety data would be very welcome indeed.Click to View the Pricing Plan
- Usefulness of Lab Testing
- The Role of the Laboratory in the AE process
- What to include as AEs in the Safety Monitoring Plan in a Protocol
- The Regulatory requirements of AE reporting
- A review of Blood Chemistry reporting situations
- A review of Hematology report issues
- Other results from the Lab and how they are used
- What types of studies require special attention to the Lab data
- Importance of avoiding the error of non-inclusion with regards to safety testing
- Demonstrate the Role of the Laboratory in the AE process
- Identify the True ‘Liver Function’ tests and the ‘Liver Injury’ markers
- Recognize how to interpret Hematological lab results
- Describe what the Urine exam tells us
- Compare Liver Injury testing with Cardiovascular / EKG testing
WHO WILL BENEFIT
- Pharmaceutical, Biological and Device Companies with an active pipeline of products and planning on global studies Principal Investigators and sub investigators
- Clinical Research Scientists (PKs, Biostatisticians) Research Managers
- Safety Nurses
- Clinical Research Associates (CRAs)
- Clinical Research Coordinators (CRCs)
- Recruiting staff
- QA / QC auditors and staff
- Study Monitors
- Clinical Research Data managers
Charles H. Pierce, MD, PhD, FCP, CPI Has 25+ years experience in the Clinical Research field. He now brings the message (via webinars, lectures and seminars) of Risk Management through knowledge 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. He has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.View all trainings by this speaker
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Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.