Regulatory Affairs & Science and Science Policy
Webcast: Developing Real-World Data and Evidence to Support Regulatory Decision-Making
Thursday, October 3, 2019
9:00 am – 5:00 pm
This conference will bring together experts to discuss the role of RWD and RWE in the regulatory decision-making setting. These experts will be examining issues addressed in the Framework for FDA’s Real-World Evidence Program, a 2018 FDA framework that outlines how the agency may use RWD and RWE to make regulatory decisions related to the effectiveness of marketed drug products.
Off-Label Use of Marketed Drugs in Clinical Trials: Investigational New Drug (IND) Considerations
Friday, November 8, 12:00 – 1:00 pm
CTRB 3256, 2004 Mowry Road, Gainesville, FL
Instructor: Sheila Austin, MS, CIP, CTSI Regulatory Specialist
The FDA IND application and submission process for the use of a marketed drug in clinical research can seem overwhelming and not worth the effort. Don’t let a terrific research opportunity slip away because you are not familiar with the process.
Bring your lunch, learn about the tools the CTSI has developed to make this process as simple as possible, and find out how the CTSI Regulatory Specialist can help you!
Presented by the CTSI Regulatory Knowledge and Support Program
Christine Mirzayan Science & Technology Policy Graduate Fellowship Program
Supported by the National Academies of Science, Engineering, and Medicine, the Christine Mirzayan Science & Technology Policy Graduate Fellowship Program provides early career individuals with the opportunity to spend 12 weeks at the Academies in Washington, DC learning about science and technology policy and the role that scientists and engineers play in advising the nation.
Graduate and professional school students and those who have completed graduate studies within the last five years may apply. Areas of study may include social/behavioral sciences, health and medicine, physical or biological sciences, engineering, law/business/public administration, or relevant interdisciplinary fields.
The application period for the 2020 Mirzayan Fellowship program has ended. The Fellowship stipend will be $9,250. For more information about the program please see: http://sites.nationalacademies.org/PGA/policyfellows/index.htm.
AAAS Science & Technology Policy Postdoctoral Fellowships
Providing opportunities for scientists and engineers to learn first-hand about policy making while contributing their knowledge and analytical skills in the federal policy realm.
Scientists in the biological, physical, health/medical, or social sciences are required to have a terminal scientific degree (PhD, ScD, MD, DVM, etc.) in order to apply for a fellowship. These terminal degrees include those in the social or behavioral sciences; medical or health sciences; biological, physical or earth sciences; or computational sciences or mathematics.
The application deadline for the 2019-2020 STPF Fellowship class has passed. For more information about the AAAS Science & Technology Policy Fellowships, please visit our website at http://www.aaas.org/stpf. Have a question? Please contact AAAS at email@example.com or 202-326-6700.
10 Science Policy Fellowships for Scientists and Science Advocates
On April 22, 2017, scientists, science enthusiasts, and concerned citizens participated in the March for Science in Washington, DC and in cities throughout the globe to celebrate science and to advocate for evidence-based policy in the public’s best interest. Want to take action beyond a march? Apply for a science policy fellowship for an opportunity to insert your expertise in the policy-making process at the state, national and global level. For information about more science policy fellowships, please link to https://www.profellow.com/fellowships/10-science-policy-fellowships-for-scientists-and-science-advocates/.
Regulatory Affairs deals with current regulations that govern development, manufacturing and testing. Current regulations cover a wide swath of work from preclinical studies, clinical trials, product testing and data analysis all the way through labeling, marketing and distribution of regulated product. Whereas Food & Drug Administration (FDA) or Environmental Protection Agency (EPA) may seem to be the most applicable, regulations also flow from other sources, such as Health Canada and the European Medicines Agency.
Regulatory science is defined as a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the life-cycle of a medicine. It encompasses basic and applied medicinal science and social sciences, and contributes to the development of regulatory standards and tools’. Regulatory science is a scientific discipline, but one conducted within a legal framework.
Photo Credit: Kevin McCoy (http://creativecommons.org/licenses/by-sa/2.0)