Webinar On 10 Steps to an FDA-Acceptable Clinical Trial Protocol

. This seminar will walk the attendee through 10 critical steps in the development of a clinical protocol. Step-by-step instructions will be provided, with case studies to emphasize the common mistakes and potential solutions.

Areas Covered in the Session :

The overall structure of a protocol and regulatory requirements

Identify who contributes to the protocol development and amendments

The element of a protocol such a background scientific rationale, design (single blind, double blind, randomized, etc.), primary and secondary endpoints, inclusion/exclusion criteria, the Schedule of Events, adverse event management, statistical parameters, informed consent, and study synopsis

Practical issues with protocol writing such a differences in various phases of clinical trials, the protocol review process, using key opinion leaders, and using public resources and templates

Common issues with FDA and IRB approval of clinical protocols.

Who Will Benefit:

Regulatory Affairs Professionals

Sponsors of INDs

Senior Management Executives (CEO, COO, CFO, etc)

Drug Discovery and Development Professionals (R&D and CMC)

Clinical Trial Managers

Project Managers and Clinical Trial Specialists

Regulatory Compliance Associates and Managers

People Investing in FDA-Regulated Product Development Projects

Price Tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299