6-Hour Virtual Seminar on Phase I GMPs

Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower doses of the drug product.

Speaker: Peggy Berry | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Speaker: Peggy Berry | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details

6-Hour Virtual Seminar on eCTD Submissions of IND/NDA to the US FDA, EU and Canada

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

Speaker: Peggy Berry | View Anytime | Duration: 6 Hours | Price: $595.00 | View Details

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details

Complaint Handling

The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages. The webinar will address aspects of the review process, SOP preparation, investigation documentation, and response to complainants.

Speaker: Peggy Berry | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details