Seminar on Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices

Overview:

The Food and Drug Administration's Center for Drug Evaluation Research, Center for Biologics Evaluation Research and Center for Devices and Radiological Health are responsible for the approval of drug products, biologics and medical devices industries. This seminar begins with outlining the structural role of the FDA and a brief introduction to the Food, Drug and Cosmetic Act (the ACT) and how the FDA uses it to enforce the regulatory requirements during the drug, biologics and medical device approval process. 

Why should you attend?

Since 1970 the regulations for conducting clinical trials has been under the direction of the Food and Drug Administration (FDA), more specifically, FDA's Center for Drug Evaluation and Research (CDER). CDER is the regulatory agency for drug applications, monitoring efficacy, safety and review process during all phases of clinical trials. 

Who Will Benefit:

This course is designed for people tasked with developing drug products, biologics and medical devices; and responsible for overseeing a company's clinical development program and regulatory strategies. This includes individuals responsible for overseeing regulatory affairs, developing strategies for establishing data safety monitoring plans, establishing adverse event databases, submitting timely safety reports to comply with regulatory compliance and those tasked with ensuring corporate compliance. Among others, this includes:

• Quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Medical device professionals
• Biotechnology and pharmaceutical professionals
• Clinical Investigators
• Study Monitors
• Quality auditors
• Data analysis specialist
• Document control specialists
• Record retention specialists
• Medical affairs
• Marketing Staff

Speaker:

Harold Thibodeaux

Research Investigator, Stiefel 

Harold Thibodeaux is a medical research scientist with in vivo pharmacological experiences in both academia and biopharmaceutical industry. During his prestigious career the focus of Mr. Thibodeaux's research efforts has been on the efficacy of cardiovascular drugs most notably Hypertension, Myocardial Infarction, Focal Ischemia (Stroke), Beyond Advair Pulmonary Research and topical antibiotics. 

Location: Raleigh, NC Date: May 19th & 20th, 2016 Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON

Price: $1,295.00 (Seminar for One Delegate)

Register now and save $200. (Early Bird)

Until April 15, Early Bird Price: $1,295.00 from April 16 to May 17, Regular Price: $1,495.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com      

Website: http://www.globalcompliancepanel.com/

Registration Link - http://bit.ly/Safety-Reporting-in-Clinical-Trials