Events

Laboratories & 1st Responders: Coordination, Planning, & Emergency Response webinar will provide researchers, administrators, and safety professionals working in laboratory facilities with recommendations and best practices on how to establish beneficial working relationships with regional emergency response agencies. This webinar will provide an overview of emergency management functions, strategies for engaging 1st responders, recommendations on how to prepare research facilities for emergencies, and breakout sessions and case studies to discuss how to build relationships, support 1st responders, develop response procedures, and conduct exercise planning. Ample time will be provided throughout the webinar to discuss participant experiences and concerns.

Biosafety professionals must grasp the complexity of various hazards present in laboratories, which include not only biological agents but also chemical, radiological, and physical hazards. This course will provide an overview of these key hazards and equip participants with the knowledge needed to assess and mitigate risks within their institutions. Topics will cover biological hazards (including risk assessments and a brief review of laboratory regulations), select agents, chemical hazards (with an emphasis on safety data sheets and hazard communication), industrial hygiene (including respiratory safety, air quality, and waste anesthetic gas management), radiological hazards (including lasers), and animal-related hazards (such as physical risks and allergens). The course will conclude with practical tabletop exercises, allowing participants to apply the concepts learned throughout the course, including risk assessment development, emergency response, and handling unique laboratory conditions.

This course is designed for biosafety professionals who are responsible for overseeing biosafety departments. The principles and practices briefly covered in this course are closely related to the Program Management Professional (PMP) certification. By understanding the core competencies of the PMP framework, biosafety professionals can apply project management methodologies to enhance the planning, execution, and evaluation of their biosafety programs. This integration of program management skills with biosafety expertise ensures that participants are well-prepared to lead effective, compliant and sustainable biosafety programs within their organizations. In addition, the course aligns with key international standards and guidelines, such as ISO 35001, which specifies requirements for a biosafety risk management system. Participants will gain insights into how to integrate ISO 35001 principles into their biosafety programs, ensuring a systematic and effective approach to biosafety risk management. The course also covers the World Health Organization (WHO) Biosafety Programme Management Associated Monograph, providing a global perspective on best practices for managing biosafety risks. By familiarizing themselves with the WHO guidelines, participants will be better equipped to implement and maintain robust biosafety programs that meet international standards.

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.

This course addresses the growing need for Biosafety Professionals to apply biosafety principles in the clinical environment. Clinical trials for biological therapeutics are becoming increasingly common. Therefore, safety professionals on regulatory committees such as the Institutional Biosafety Committee must possess a strong understanding of clinical safety, terminology, and regulatory requirements in order to perform an adequate risk assessment of the proposed hazard mitigation measures for these studies. In this course we will explore various clinical spaces, their unique biosafety considerations, and relevant hospital regulations that apply to patient safety, staff safety and a safe environment of care. You will also acquire the knowledge necessary to apply these safety practices in accordance with both research and clinical safety regulations while developing, in collaboration with clinical colleagues, processes that maintain staff safety at all levels.

As AI becomes increasingly integrated into laboratory operations and risk management, it presents both challenges and opportunities for improving safety and mitigating biological threats. This advanced workshop builds on last year’s course, focusing on biosecurity risk assessment frameworks for AI-enabled systems, with a focus on embodied AI agents and automation. Drawing from recent advances, including the use of humanoid robotic systems with AI in high-containment environments, this course will combine theoretical foundations with hands-on applications. Attendees will engage in case studies and group exercises to assess biosecurity risks associated with AI-driven tools and systems in laboratory settings.

This four-hour course provides an in-depth look at the anatomy of an Institutional Biosafety Committee (IBC) meeting, exploring its role within the broader biosafety program. Participants will gain a comprehensive understanding of IBC meeting operations, including committee structure, member responsibilities, and the processes that ensure compliance and risk mitigation. Topics covered include the intersection of biosafety programs and IBC functions; roles and responsibilities of IBC members, biosafety staff, and ad-hoc consultants based on their expertise; managing nonconformity issues and implementing corrective actions; the role of pre- and post-IBC meetings in streamlining operations; utilizing the IBC meeting matrix to improve efficiency and decision-making; engaging special reviewers and external consultants when needed; structuring an IBC meeting into different sections such as recombinant DNA, infectious agents, IRE, and subcommittees; handling NIH reportable incidents and urgent post-submission requests; and understanding IBC registration forms, help documents, and compliance tools. Through case studies and discussion-based activities, attendees will leave with a clearer understanding of how to effectively contribute to and enhance IBC meetings. This course is ideal for current and prospective IBC members, biosafety professionals, and institutional stakeholders involved in biological research oversight.

The course is intended to introduce biosafety professionals to host-pathogen interactions by focusing on fundamentals of immunology, microbiology and their interplay as they pertain to biosafety risk assessments utilizing instructional videos, case studies, established lab acquired infections and publications. Information from this course can assist biosafety professionals assess risks from microbiological research including potential effects of genetic modifications on virulence and infectivity of pathogens, susceptibility of hosts in in-vitro and in-vivo models for IBC review, assessing impact to the wellbeing of research animal hosts for IACUC review, as well as the occupational safety and occupational health of research personnel.

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 attendees 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 attendees’ individual programs and providing a platform to capitalize on attendees’ collective experience.

Virus-based Gene Transfer Vectors is an intermediate course that will examine the molecules, processes, and techniques involved in recombinant gene expression. Participants will explore the technology of how viruses are converted into vector systems for the transfer of gene expression constructs. Common viral vector systems, including retroviruses, lentiviruses, adenoviruses, poxviruses, herpesviruses, alphaviruses, and baculoviruses will be discussed with an emphasis on the biosafety characteristics of the vectors derived from these viruses. This course is targeted for the biosafety professional who is not actively conducting laboratory research yet requires a basic understanding of recombinant DNA methodology.

This course is tailored for individuals responsible for establishing and overseeing infectious substance shipping programs within their facilities. This webinar series aims to assist institutions in developing robust shipping programs tailored to their needs. Course elements include: training; written policies; written descriptions of program plans; transport and shipping specific SOPs; safety and security plans; emergency response plans; logistics and supplies; carrier selection and support; MOUs and authorizations; access control and personnel assurance. The instructor will provide a detailed and comprehensive shipping program assessment and implementation guidance document. Attendees will receive an introduction to this document and step-by-step guidance on its completion. By completing the assessment document, attendees will conduct a thorough review to identify areas for improving existing shipping programs. This interactive, instructor led, web-based training will invite attendees to share examples of how these elements are addressed at their own institution.

Part I Foundations and Frameworks – Plant and plant pest research is the backbone of both genetically modified, disease resistance and breeding of both academic and biotechnology research so it is important that research is conducted legally and ethically. The first webinar will cover the importance of having the Material Transfer Agreement (MTA) in place before research begins and a Non-disclosure Agreement (NDA) to protect confidential business information (CBI) and Intellectual Property (IP) rights. We will discuss the Cartagena Protocol on Biosafety, which is an international agreement on biosafety and a supplement to the Convention on Biological Diversity to understand requirements for access and benefit sharing between countries. The class will walk you through setting up an eFile account which is used for applying for permits. This will be the first session of 2 and it will be conducted over a 2-hour period with time for questions and answers. Part II: Federal Compliance – PPQ, BRS, VS, PHYTO, EPA, Biopesticides, Wildlife & Fisheries – The second part of the series will provide participants with an overview of the federal regulations that allow you to import, export and move biological material inside and outside the U.S. legally. The class will expand on the first session by walking you through the ins and outs of applying for different permits. This course will cover the foundations of whether a permit is needed, how to apply for a permit, what type of permit you need, permit conditions, and the result of non-compliance.

Intro to Flow Cytometry Biosafety will provide safety professionals and anyone working in a laboratory setting a foundation on flow cytometry and cell sorting and strategies for mitigating the risks associated with typical flow cytometry instrumentation and procedures. This course will include a detailed overview of how flow cytometers work, common sample types that are handled in flow cytometry laboratories, a typical flow cytometry workflow, and considerations for core facilities/shared resource laboratories. The risks associated with flow cytometry and cell sorting will be discussed as well as mitigation strategies that can be implemented to reduce these risks. The course will be presented by experts from the International Society for Advancement of Cytometry (ISAC) Biosafety Committee and will include an overview of the ISAC Biosafety Standards. This course will include lecture material, breakout sessions where attendees will evaluate risks and develop plans for risk mitigation using real-world examples, and ample time for questions.

From Expertise to Influence is a practical course designed for biosafety professionals seeking to amplify their voice in an increasingly digital landscape. In this course, attendees will discover how artificial intelligence (AI) tools can help create compelling content, streamline personal communications, and establish oneself as a thought leader in biosafety. Examples will be shared of how to better communicate at work and beyond while avoiding common AI pitfalls like generic messaging, factual errors, and loss of your authentic voice. Presenters will explore the latest LinkedIn features and algorithm changes that impact how biosafety professionals can reach colleagues, organizations, and industry partners. Finally, strategies will be shared for optimizing your profile and content for maximum engagement and visibility. At the end of this course, attendees will be able to apply these insights—understanding public relations role in personal branding and the items needed for their personal checklist, to elevate their digital professional presence. This course will be led by communications experts with over 25 years’ experience developing and sharing messages with a wide variety of target audiences in brand-building and crisis situations.

The clinical setting poses a different environment than research laboratories. This course provides foundations for applying biosafety concepts in the clinical setting. Course topics 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 group exercises.

This webinar will first summarize the content of the ANSI/ASSP Z16.2-2022 Safety and Health Metrics and Performance Measures report and then provide tangible examples of how actual biosafety program data can be collected, displayed, communicated, and used as the basis for programmatic decision-making while meeting the criteria described in the report. The webinar will include group discussions focused on discovering what data is currently being collected and what data is expected by organizational leadership, so participants are asked to come prepared to describe their respective measures and metrics that are currently being used and which parameters other stakeholders are seeking. The importance of capturing and communicating this information to “sell” your biosafety program to organizational stakeholders will be featured. The ability to effectively “sell” your program can help garner necessary program support and resources for success. Ample time will be allotted for participants’ questions and discussion.