Seminar / Training
Attend this seminar to design the most appropriate strategy for a clinical program, including all clinical developmental phases from IND to NDA/PLA.
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.
Participants will learn about similarities and differences in clinical strategies for standard vs unique molecules, for domestic vs global programs, and for large pharma projects vs small biotech companies.
- 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.
- To become familiar with common challenges and key issues effecting trial designs and their execution in different countries and difficult investigators.
- To understand how to work with multifunctional and often multicultural teams.
- To discuss the clinical part of FDA and ICH guidelines and their impact on clinical programs.
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.
- Any college graduates who are contemplating careers in clinical research involving the bio-pharma industry.
Note: Use coupon code < NB5SQH8N > and get 10% off on registration, Valid till Dec 31st 2016.
Organizer : Compliance online
This webinar on Objectionable Micro-organisms will provide examples of objectionable microorganisms and will review specific actions to take when one is found. It will also review how to conduct an effective risk analysis to mitigate the risk they present.
Since the prosecution of off-label uses has intensified, companies need to revisit everything they do in the off-label arena. While off-label “sales” have never been illegal, because physicians can and do lawfully prescribe products for off-label uses, off-label “promotion” is illegal.