Online Webinar 2019 - 21st Century Cures Act -New Guidance on Medical Device Software Compliance

Session Highlights
• 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
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.
Who Will Benefit
Professionals in the following industries may also benefit from the content:
• Pharmaceutical
• Medical Device
• Biotechnology
• Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
• Information technology managers and analysts
• QC/QA managers and analysts
• Clinical data managers and scientists
• Compliance managers
• Lab managers and staff
• Automation analysts
• Computer system validation specialists
• GMP training specialists
• Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit
• Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance
• Anyone involved in the planning, execution, and reporting of a clinical trial (sponsor, director, researcher, regulatory role, etc.)
Overview
The 21st Century Cures Act is a United States law enacted by the United States Congress in December 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health (NIH). The act was supported by large pharmaceutical manufacturers and was opposed especially by many consumer organizations.
The intent of the Act is to streamline the drug and device approval process and bring treatments to market faster. Many fear that this will allow drugs and devices to be approved on weaker evidence, bypassing randomized, controlled trials, and bring more dangerous or ineffective treatments to market.
The bill incorporated the Helping Families In Mental Health Crisis Act, which increased the availability of psychiatric hospital beds and care.
The 21st Century Cures Act designated $1 billion in grants for states over two years to fight the opioid epidemic, which is surging in the US. The money may be used to improve prescription drug monitoring programs to make treatment programs more accessible, to train healthcare professionals in best practices of addiction treatment, and to research the most effective approaches to prevent dependency.
The 21st Century Cures Act modified the FDA Drug Approval Process. It was intended to expedite the process by which new drugs and devices are approved by easing the requirements put on drug companies looking for FDA approval on new products or new indications on existing drugs. Under certain conditions, the act allows companies to provide "data summaries" and "real world evidence" such as observational studies, insurance claims data, patient input, and anecdotal data rather than full clinical trial results.
The 21st Century Cures Act allows researchers to waive the requirement for “informed consent” in specific cases where the devices being tested don't pose any health risks beyond those of normal everyday life and wouldn't direct a patient's care in any way. However, researchers will still need to obey standard research protocols including Institutional Review Boards (IRBs) to approve their research design and ethics.
Speaker Profile
Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.