Overview of clinical drug development from final preclinical selection, marketing approval, all phases of clinical trials, new strategies, challenges

Participants will be introduced to major clinical steps and considerations in the new drug development process. Starting with the selection of medically promising molecules, through the execution of major I-IV phases of clinical trials, and ending in clinical profiling for marketing.

The course will address:

Standard procedures;

New strategies implemented in clinical trials;

Selection of clinical investigators, consultants and opinion leaders;

Interactions with regulatory agencies in various countries;

Impact of regulations on the programs; as well as other common challenges.

Learning Objectives:

To understand the role of medical input in the selection of potentially therapeutic molecules and their subsequent clinical profiling.

To understand and be able to design the most appropriate strategy for a clinical program, including all clinical developmental phases, from IND to NDA/PLA.

To understand basic trial methodologies, study execution, monitoring and evaluation processes.

To understand the selection of the investigators and consultants in various countries; the criteria for study placement and their cost, as well as the concept of “go no go” clinical decision for the molecule.

Who will Benefit:

Junior or new staff of clinical pharmacology and clinical research departments.

Pre-clinical, business, legal and marketing professionals who wish to become familiar with the clinical drug development process and the interpretation of clinical data.

Investment or licensing community members who are interested in clinical programs, particularly in the process of planning, costs, timing and issues of clinical evolutions and/or profiling of new molecule.

Clinical research associates, project managers, research scientists, medical writers, clinical statisticians, junior regulatory personnel, licensing and acquisition staff.

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/clinical-drug-development-process-seminar-training-80325SEM-prdsm?channel=sciencedz