Regulatory Open Forum

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Call for Reviewers - RAPS Online Courses

Signup Deadline: 26-Feb-2021

Starts: 08-Mar-2021

Ends: 10-May-2021

Location: Online Opportunity

Description:

RAPS Online University provides regulatory professionals with education options to hone their skills in specific areas of expertise. We provide individual courses on a variety of regulatory topics, from the basics to product- and region-specific subjects. In order to ensure these courses are valuable and up-to-date, we recruit members to review and make recommendations on them.

We are currently recruiting four (4) individuals to review the following courses:

Ethics
This course identifies and analyzes ethical issues regulatory professionals may encounter and provides a general introduction to complex concepts, principles and theories, including bioethics and legal principles. It highlights ethical issues in areas of product development, compliance and clinical testing. This course is intended to be a companion piece to the RAPS Code of Ethics, as well as your own institution’s policies, procedures and training programs.

Biosimilars
This first part of the course will examine the sources of complexity in biologics and their production processes. The remainder of the course will provide an overview of the current guidance documents available to address the regulatory approval pathways for biosimilars, and compare the quality, nonclinical and clinical aspects of biosimilar development in three major regulatory jurisdictions, namely the EU, US and Canada.

Pharmaceuticals: US Regulation
Last published in 2016, this course gives all user an in-depth understanding of pharmaceuticals in the US, beginning with historical justifications for why some pharmaceutical regulations exist today, and then take the plunge into an all-inclusive exploration of the current state of US pharmaceuticals. As pharmaceutical companies continue to apply innovative scientific methods, the ability to understand and accurately interpret applicable regulations and guidance is critical to both successfully managing a product’s lifecycle and to protecting public health.

Medical Devices: Advertising and Promotion in the US
This course provides information on the US agencies that regulate medical devices, their enforcement tools, as well as strategies to avoid enforcement actions. Included are guidelines on the information needed for a regulatory review of medical device advertising, methods used to identify claims in promotional materials and how to evaluate evidence to substantiate various types of claims. A review of current promotional issues and enforcement trends also is included.

Volunteers will review the course's content, as well as final assessment, and references and resources.

If interested, please click "Apply Today!" and complete the application. The application will ask you to identify the course that you'd like review.

This opportunity will take approximately 8-20 hours. If selected for this opportunity, the RAPS Online University manager will reach out to you directly.

RAC holders may claim RAC recertification credits upon completion of this volunteer task. The number of credits will vary for each course reviewed.

The application must be received by 26 February 2021.

Qualifications:

Biologics/biosimilars/vaccines

Europe

Medical Devices

North America

Pharmaceuticals

Volunteers Needed:

4 (0 open slots)

Experience Required:

At least 3 years of experience

Volunteer Stars:

Contact:

Danielle Fezell