Adverse Events Web-based Seminars

First in Class First in Man Compounds Targeting Tumor Bioenergetics from Lab Bench to Clinical Trials Working with the FDA to me Overview: Many anticancer drugs are not tumor selective. For chemotherapy the lack of drug and disease specificity and need for higher dosing leads to adverse and serious adverse events that may be dose limiting. Preventing a therapeutic level to be achieved in a patient. Thursday, June 28, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Lipid Based Formulations and Targeting Tumors - FDA Considerations of Nanotechnology in Drug Manufacturing Drug Delivery and Dru Overview: Many anticancer drugs are poorly soluble and require higher dosing to achieve some level of delivery to tumors and tumor cells. For chemotherapy the lack of drug and disease specificity and need for higher dosing leads to adverse and serious adverse events that may be dose limiting. Tuesday, June 12, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Essentials of Drug Safety and Pharmacovigilance - Webinar By GlobalCompliancePanel This webinar is designed to give pharmaceutical and biologic companies operating in the U. S. and EU an introduction to the fundamentals of product safety and regulatory compliance. The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities. Thursday, April 19,  more...

Adverse Event Reporting for Dietary Supplements and OTC Drugs - Webinar By GlobalCompliancePanel Since passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs. Manufacturers and importers of products in these categories often have questions about what constitutes a serious adverse event and about Adverse Event reporting requirements that this Webinar will be able to  more...

The Risk to Subject Safety of Not Accurately Reporting Adverse Events - How to Assess and report AEs and SAEs - Webinar By Globa The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately.  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...duct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects. See why AEa ™s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/ his charge. Learn how well-controlled and well-conducted clinical trials that follow the  more...

Recalls Vigilance - When to Report Complaints - Webinar By GlobalCompliancePanel ...quaint one with the lessons learned from over 30 years of adverse events and complaints. FDA has issued warning letters for failing to properly evaluate medical device complaints for reporting under 803 & 806 regulations. Vigilance reporting is also required in Canada, the European Union and many other countries. Warning letters and recalls are posted on FDA's website and published in trade  more...

Regulatory Complaint Handling Vigilance Recalls - Webinar By GlobalCompliancePanel ...ew the regulatory requirements for complaint handling and adverse events reporting in the USA, EU & Canada. Suggestions for investigating and documenting complaints & pitfalls will be included. Areas Covered in the Session: * Complaints Definitions; FDA, EU & Canada * How to Document Complaints & Adverse Events * US & Foreign Regulatory Reporting * Recall, Vigilance,  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ...blems with the MDR regulations and reporting of potential adverse events and possible device malfunctions. The regulation has been unchanged for several years, but FDA continues to find violations of these regulations. Both large and small manufacturers have been cited by FDA investigators as a result of directed and routine inspections. Findings include lack of procedures, not following  more...

101 cGMP To-Do List for 2011 - Webinar By GlobalCompliancePanel Overview: This webinar will examine the broad range of issues a company's senior management and QA/ RA need to consider in their annual Management Review of their existing quality management system. Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry)  more...