The 21st Century Cures Act - Expediting New Products and New Product Indications - Recorded Webinar

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Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Carolyn Troiano

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

The law builds on FDA's ongoing work to incorporate the perspectives of patients into the development of drugs, biological products, and devices in FDA's decision-making process. Cures enhances our ability to modernize clinical trial designs and clinical outcome assessments, which will speed the development and review of novel medical products, including medical countermeasures.

It also provides new authority to help FDA improve our ability to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs, including:

The Regenerative Medicine Advanced Therapy, or RMAT, that offers a new expedited option for certain eligible biologics products
The Breakthrough Devices program, designed to speed the review of certain innovative medical devices

In addition, the Cures Act directs FDA to create one or more inter-center institutes to help coordinate activities in major disease areas between the drug, biologics and device centers and improves the regulation of combination products.

Why should you Attend: Providing safe and effective drugs and medical devices is in the best interests of all those involved in the development, manufacturing, testing, and distribution of these products. In the case of the opioid epidemic, there is great interest in providing better medications and healthy pathways for treatment.

This webinar will help explain how the 21st Century Cures Act will impact the current pharmaceutical and medical device industries, particularly their processes for new product and new product indication requests.

Anyone working in the pharmaceutical and medical device industries who engage in research, development, testing, manufacturing, and supply chain functions will benefit from this presentation.

Areas Covered in the Session:
- The 21st Century Cures Act
- New processes for expediting drug and medical device approval for new products and new product indications
- How to prepare for the Act
- Industry Best Practices
- Q&A

Who Will Benefit:
- Medical Device Manufacturing
- Testing
- Packaging
- Distribution companies
- In some cases, the Medical Device Software will be provided by a Software Development firm vs. the medical device company itself
- In some cases, the Medical Device will deliver a drug to a patient, and so those working in the Pharmaceutical and/or Biotechnology Industries may have some interest in this topic

Carolyn (McKillop) Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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