For the past 30 plus years, the label “For Research Use Only” has been confusing to many medical and research professionals as well as marketing and sales personnel.
Additionally, these products remain unregulated without Food and Drug Administration (FDA) oversight. As the industry transitions into the age of molecular diagnostics to remain innovative with the pharmaceutical industry efforts to develop medical products for unmet medical needs, FDA regulatory oversight is need more than ever.
Although these products remain an important commercial class, a regulatory framework to regulate their development, manufacture and distribution for the appropriate laboratory intended use.
The topics for discussion in this webinar will be summarized to provide lists of dos and don’ts for marketing, sales personnel, manufacturers and research professionals to achieve their goals, remain compliant and to develop products that will be safe and effective for use in patients. An appropriate regulatory framework will promote innovation for those unmet medical needs instead of being an obstacle to it.
Why Should You Attend:
This webinar is an important first step for both professionals, both marketing and sales, to take as they promote and distribute Research Use Only (RUOs) for use by medical professional in clinical laboratories and investigational ones as well. RUOs are important commercially available products that have been in both basic and clinical laboratories.
With the constant change in technology in both medical devices and products used in the clinical diagnosis of diseases, marketing professionals need to have knowledge as to the regulation requirements for their specific products.
Areas Covered in this Webinar:
Research Use Only (RUOs) has and plays a significant role in clinical development including the drug development process – clinical trials. Although unregulated by the FDA, attendees will learn about the Code of Federal Regulations which plays a major role in the regulatory and labeling requirements of RUOs that both manufactures and sales representative need to be aware of.
This webinar will also discuss the several Guidance Documents issued by the FDA in attempts to regulate RUOs and the lack by the agency to enforce the regulations outlined in them. Current thoughts and positions of the FDA to regulate will be discussed with special attention to “letters written by member of Congress sent to Congressional Committee” and a Bill introduced in 2013 which if enacted will change the landscape of RUOs for the future.
• Definitions of Research Use Only – what are RUOs?
• Code of Federal Regulations for Research Use Only Products
• Guidance Documents Issued by the FDA
• Labeling Requirements for RUOs
• Good Manufacturing Practices
• Letter from Members of Congress to the Commissioner of the FDA
• Congressional Bill regarding FDA’s Authority for Research Use Only Products
Who Will Benefit:
• Preclinical Researchers
• Clinical Researchers
• Sales and Marketing Staff Personnel
• Laboratory Compliance Office
• Biotechnology and Pharmaceutical Professionals
• Risk/Compliance Officers in the Clinical fields
• Good Manufacturing Practice Managers
Harold Thibodeaux is a medical research scientist with in vivo pharmacological experiences in both academia and biopharmaceutical industry. During his prestigious career the focus of Mr. Thibodeaux’s research efforts has been on the efficacy of cardiovascular drugs most notably Hypertension, Myocardial Infarction, Focal Ischemia (Stroke), Beyond Advair Pulmonary Research and topical antibiotics. Optimal therapeutic benefits were the goal in all of these projects but cardiovascular safety to provide safer medicines to patients was a priority.
Mr. Thibodeaux transitioned into the pharmaceutical industry when he joined the Cardiovascular Department of Genentech in 1990, as a technical lead with the Second Generation TPA Project Team. Mr. Thibodeaux is a graduate from the College of Charleston with a Bachelor of Science Degree in biology and is a member of The Safety Pharmacology Society.
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