The clinical setting poses a different environment than research laboratories. This course provides foundations for applying biosafety concepts in the clinical setting. Topics covered include common issues and lessons learned pertaining to clinical facilities including pharmacies, laboratories, clinics, infusion areas, ORs, and waste disposal facilities; PPE, disinfection, risk assessments, and safety practices in the clinical setting; speaking biosafety to doctors, nursing staff, pharmacy staff, infection prevention and control, diagnostic microbiology lab personnel, and hospital EHS staff; applying NIH Guidelines and the BMBL to the clinical setting; gaps in oversight of research safety for clinical trials, and risk assessments for unconventional or highly specialized delivery mechanisms for biologics. The course will conclude with a focus on clinical trials including the role of an IRB and how it can overlap with an IBC; the process for investigational products to obtain FDA approval to be deemed as safe and effective therapeutics; and the evolving regulatory environment in the U.S. for biologics such as vaccines, regenerative medicines, and gene therapy. The course is designed to be highly interactive with discussions, surveys, and team exercises.

The use of recombinant and synthetic nucleic acid molecules in clinical trials is growing at an explosive pace. This course is intended to introduce biosafety professionals to the science and biosafety of gene-based investigational products in clinical trials including gene-based vaccines, gene modified cellular products, gene therapy and gene editing. This course will provide an overview of molecular biology, virology and viral vectors. Participants will discuss risk assessments and best practices for dealing with risks associated with diverse types of biological hazards.

Plant Biosafety is a niche within the biosafety community. How to build and maintain a greenhouse, arthropod and seed processing program can be challenging for biosafety managers because there have not been many courses offered on this topic. This class offers the basics from head house to pathogen/arthropod containment greenhouse design. Plant research is the backbone of both genetically modified, disease resistance, growth enhancement, seed health and breeding of both academic and biotechnology research. Plant biosafety is a niche within biosafety that makes you ask – Do the engineers and project managers understand the need for and when to ask for biosafety input? This course will provide participants with an overview of designing greenhouses from headhouse, seed activities to arthropod containment using the APHIS and ACL containment guidelines. The course will offer a variety of advanced scenarios and interactive exercises that demonstrate the range of biological and other risks routinely encountered in plant research. Participants will be guided through strategies for identifying potential hazards, assessing the magnitude and extent of induced risks and cost, and developing effective control measures to protect the safety of workers, plants, and the environment. The course employs “real world” examples to improve understanding of greenhouse, arthropod and seed operations.

Safety for NonProfits Inc. and the Biosafety Professional A free webinar Friday, September 22, 2023 2:00pm (CDT) Register Now Registration for the live webinar must be completed 1 business day prior to the start of the training. Registrations received after will receive access to the recording only. Thinking about providing your biosafety (or EHS) expertise to a non-profit charity organization or currently donating time and knowledge to a non-profit? Hesitant to volunteer without professional liability insurance or don’t know where expertise is needed? Now there is a way to do that important pro-bono work and be covered by [...]

IBC Basics is an introductory course on the function and administration of Institutional Biosafety Committees (IBCs) delivered by expert staff from the National Institutes of Health (NIH) Office of Science Policy (OSP). IBC Basics will promote the professional development of those associated with IBCs by providing an opportunity to learn about the role of NIH OSP, the content of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules, and understand the range of biosafety oversight responsibilities that IBCs have under the NIH Guidelines. This course provides an overview and may be helpful for those new to the field or for those who are also interested in the Institutional Biosafety and Biosecurity Oversight Governance workshop.

Keeping a select agent program going can be difficult, especially in the face of ever-changing regulatory requirements and limited resources. Established procedures may suddenly become unacceptable, interrupting research, and frustrating laboratorians. Likewise, a single unexpected adverse event can put an entire program at risk. Being prepared to deal with such changes and events is critical to maintaining a robust program. Anticipating future challenges can be even more advantageous, elevating a program from good to great. A proactive approach can minimize the impact of new requirements and reduce duration and frequency of crises sparked by sudden, unexpected requirements or events. This course will explore strategies for maintaining and improving an existing program, including how to anticipate and respond to new requirements. The focus will be on U.S. select agent requirements, although a small section on comparable requirements in the international community will be included. Strategies will be based on the instructors’ experience with their program with additional input solicited from class participants during open discussions. Topics will include select agent program history; effective oversight; efficiently meeting ongoing requirements; reporting, responding to, and analyzing incidents; suitability program case studies; inactivation requirements, including “failure” investigation; and inspection preparation and response. The course will consist of topical presentations followed by group discussions aimed at facilitating application of presented strategies to participants’ individual programs and providing a platform to capitalize on participants’ collective experience.

Recent infectious disease outbreaks highlighted the need for the proper use of Personal Protective Equipment (PPE). The guidance on use of appropriate PPE varies greatly and can often be contradicting and therefore confusing to the end user. Furthermore, availability of different PPE often varies depending on the situation and location. Selection of appropriate PPE should be based on a comprehensive risk assessment that takes in consideration the different hazards present, as well as the procedures/activities to be conducted. Often times, locations where PPE is needed vary as well, from a well-controlled laboratory environment to collection room or a field location, and even in a patient room setting. Each of these situations require staff to be able to perform a comprehensive risk assessment, often in a fast-evolving situation and with a minimal understanding of specifications associated with different PPE components available to them. This course will provide overview of different PPE options available; specifications associated with each option, and address a risk assessment process for selection of appropriate PPE for different environments. The examples will include some of the most common issues and considerations when selecting PPE such as supply chain issues as well as strategies to address behavioral concerns that may arise. In groups, participants will develop risk assessment for different scenarios, present their risk assessment to the class, and evaluate each other’s PPE selection based on their risk assessment. Instructors will guide participants through the process by providing critical feedback on the PPE features and selection process as they progress. The course will go through an effective risk assessment process which is critical for proper selection of appropriate PPE. The course is intended for those who want to be able to lead or aid in the selection of appropriate PPE in order to enhance both biosafety and biosecurity at their institution.

The FBI’s Weapons of Mass Destruction (WMD) Program and Safeguarding the Bioeconomy webinar will demonstrate how the FBI’s WMD Program interfaces with biosafety officers. This information can be helpful especially as biosafety offices deal with the evolving threat that biotechnology can pose. With its rapid growth, the U.S. bioeconomy increasingly serves as a critical foundation for American competitiveness in a global environment. When it comes to security, biological threats have historically focused on emerging infectious diseases or the possibility of engineering a virus that could start a zombie apocalypse. As biology continues to converge with cyber, new security challenges will arise. This presentation will highlight the need to radically redefine what we consider biological and cyber threats.

This course will offer guidance of key principles underlying the programming and design of research and diagnostics laboratories. It is intended for architects, designers, and biosafety professionals desiring an increased awareness of the complexity and challenges associated with designing a laboratory. Participants will be introduced to the laboratory design process as it relates to programming and pre-design, building zoning, operational efficiency, biosafety and biosecurity considerations, and flexible/expandable strategies. Participants will participate in guided discussions, develop diagrams to illustrate best practice concepts, and analyze existing plans with respect to the design principles under discussion.

This course will discuss the importance of ensuring institutions have robust and comprehensive biosafety and biosecurity governance structures in place. Information will be provided about Federal activities related to strengthening biosafety and biosecurity practices and oversight. Participants will discuss and share tools and best practices that institutions can employ to enhance their biosafety and biosecurity programs.Participants will break into small groups to discuss a case study involving a biosafety incident occurring at an institution subject to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), which illustrates the importance of institutional biosafety oversight and how inadequate local oversight can result in significant problems. Participants should ideally have a working knowledge of the roles and responsibilities of institutions, Institutional Biosafety Committees (IBCs), and Institutional Review Entities (IREs) for biosafety and biosecurity oversight of research subject to the NIH Guidelines and the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC).