Introduction of FDA Regulatory Education for Industry (REdI) Annual Conference 2021

There are many educational events  in FDA throughout the year that focus on the pharmaceutical and regulatory industries. One that combines both is the Regulatory Education for Industry (REdI) Annual Conference, and its most recent event took place on July 19–23, 2021. This complimentary conference offered three central tracks: drugs, devices, and biologics, gathering a lot of regulatory experts to discuss their field and provide a strong foundation in FDA’s regulatory requirements. The conference functions as an introductory course that leaves attendees with a clear understanding of the FDA’s processes and guidelines for the three tracks that it provides. (1)

This general plenary focused on the FDA and the emergency use Authorizations and other resources that make products available to the public in the face of the COVID-19 pandemic. The pandemic presented a public health emergency that required medical supplies products to be used in unapproved ways or even allow the use of unapproved products to protect life and treat diseases in the absence of alternatives. The plenary brought together the three directors of the FDA Center for Drug Evaluation and Research (CDER)， Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER), focusing each on their particular perspective. (2)

The conference was split into three tracks. A common theme was the impact of the COVID-19 pandemic on the three fields.

Drug Track 

In regards to the drug track, there were several conferences throughout the event. The first one,  by the director of the OND or Office of New Drugs who discusses the reorganization and restructuring of the OND and the New Drugs Regulatory Program Modernization. Another conference concerns the efforts of the CDER to modernize as well. The attendants were introduced to the CDER NextGen Portal, a cloud solution for drug standards, and to the use of the Electronic Common Technical Document (eCTD). There was a spotlight throughout several conferences on how different institutions have adapted to COVID-19, the use of emergency use authorizations for the drug field, as well as a concern with best practices and new drug development in pandemic times. There was a lot of concern with best practices for communication, regulation, and medical trials during this period of uncertainty when public health becomes especially important .(2)

Device Track

The device track focused on device regulations, how they worked, and how it was possible to speed the approval process through best practices. It introduced the Q-Submission Program, which provides applicants with the option to request feedback and meetings with the FDA throughout the product development and approval cycle. There were two conferences focused on the 510(k) Program, the most common pathway to market medical devices in the United States, considering the legal and practical issues involved. (2)

The conferences introduced the Bioresearch monitoring program or BIMO, run by the FDA, that inspects and audits data for devices, providing practical advice on what to expect from an inspection and how to make it more successful. (2)

Other important aspects that were addressed by the speakers involved CAPA or the Corrective and Preventive Action subsystem, the Manufacturer and User Facility Device Experience or MAUDE database that contains all the reports submitted to the FDA, Additive Manufacturing and the existing technology, and, finally, a detailed analysis of Class I and Class II recalls that have taken place to help manufacturers navigate the process. (2)

Biologics Track

The biologics track involved speakers discussing different aspects of manufacturing involving biological products. For instance, there was discussing of 21 CFR Part 1271 (known as the "Tissue Rule"): HCT/Ps Regulatory Framework, highlighted the development of advanced therapies, including human cellular and tissue-based products, gene therapies, plasma-derived therapeutics, and devices regulated by the CBER. The presentation considered the regulations in place. The basics of biologics submissions and the pathway towards the Biological License Application or BLA were presented. (2)

There were speakers talking about the process of developing cellular therapies and gene therapies, from the pre-clinical stage and the importance of consent to the clinical trials, as well as pointers on how to expedite the process and how these products can be employed at the moment. The biologics track, perhaps, had the biggest focus on ethics, as expected for something with such potential but also potential minefields. (2)

Overall, the Regulatory Education for Industry (REdI) Annual Conference was focused on several key elements. First, it sought to introduce attendees to the basics and nuances of regulatory practices for their specific field, considering what they should expect and the pitfalls of the process. A lot of attention was given to COVID-19, specifically, how different organizations within the field have adapted to the pandemic and what it means for the future. There was also a lot of attention on introducing and explaining the existing programs, tools, and options to make everything faster or more effective, for example, getting meetings and feedback from FDA personnel directly. With a highly comprehensive approach, the conference provided a solid overview of important topics and the opportunity for attendees to learn the basics and ask their questions during the panels or the Q&A sessions.

The conference has been pre-approved by Regulatory Affairs Professionals Society (RAPS), Society of Clinical Research Associates (SOCRA), Society of Quality Assurance (SQA) and Association of Clinical Research Professional (ACRP) for continued education and development for clinical researchers and other professionals. (3)

In regards to the pharmaceutical industry, this is an important conference. It addresses manufacturers’ concerns and makes the process of receiving FDA approval more accessible and transparent, allowing professionals to learn more about the tools at their disposal and the basic regulatory guidelines, requirements, and pitfalls as well. It is important for an industry-wide communication process that allows attendees to understand how different organizations are adapting to COVID-19, the changes and modernization of the submission, review, and research processes, for instance, with new databases and online tools. 

The panels and talks for the conference are available on YouTube and can be accessed, alongside other materials, such as the agenda, the slides, and more on the SBIA events page https://sbiaevents.com/redi2021/. 

This was the first annual conference focusing on these three tracks and with top-level speakers from each field, is likely to have a significant impact on the industry as it currently is, offering easier access to information and a reference point for individuals who want to understand the details and the processes of something as complex as regulatory practices.

References

1. SBIA. (2021). FDA Small Business Regulatory Education for Industry (REdI) Annual Conference https://sbiaevents.com/redi2021/

2. SBIA. (2021). Agenda. https://sbiaevents.com/files2/REdI-2021-Agenda.pdf

3. SBIA. (2021). Session Recordings. https://sbiaevents.com/redi2021/

About the Author

Lin Zhang, M.D., senior director of a health care industry company in the United States. With the experience in clinical medicine, biotechnology, health industry and other fields, he is responsible for the research and development of plant medicine, functional food and health products. He was a clinician and worked for the National Cancer Institute, FDA and the National Cancer Center of Japan for many years.