Right to Try Legislation: Impact on Industry, Health Authorities, and Patients

Teachers
Michael Pierro
Category:
Clinical Trials & Good Clinical Practices (GCP) Training/ On-Demand Courses/ Quality/ Regulatory & Compliance/ Research & Development/
Duration: 90-Minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

“Right to Try” laws allow terminally ill patients to receive treatment with experimental drugs, biological products or medical devices that have passed the first phase of the FDA/Health Authority approval process, but have not been fully approved for public use. To date, 40 states within the US have “Right to Try Laws” in place. Additionally, a federal version of the Right to Try Law (Bill H.R.878) was recently signed into law by the President of the United States.  The opportunity to have your promising therapy available to assist patients and gather real-time clinical data is very exciting. However, you must understand the laws and map your Right to Try programs on a risk-mitigated compliance path.

LEARNING OBJECTIVES

This webinar will discuss how you can maintain compliance while treating patients under the Right to Try Laws. By attending this 90-minute interactive session, you will learn:

  1. Current status and meaning of the “Right to Try” Laws
  2. Specific requirements for implementation and compliance by the Sponsor, Investigator, and Patient
  3. Specific risks to Sponsor and Investigator
  4. How to gather meaningful “Right to Try” data and what to do with it
  5. The impact on the Marketing Authorization process

Who Should Attend

WHO SHOULD ATTEND

This course will be of value to anyone working in clinical trials, but will be of specific interest to the following groups:

  • Individuals from industry, academia and CROs who are involved in designing and implementing clinical trials phases II and III
  • Clinical Project Managers and Study Managers

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Michael Pierro
Michael Pierro, a highly experienced facilitator and subject matter expert, provides clinical operations and GCP/SOP training to the biotechnology, CRO and pharmaceutical industry.

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