Insights to Impact | Biopharma 4.0 Playbook: Quality, Compliance & AI in the New Regulatory Era
BioPharma is in the midst of a transformation shift with several converging trends sweeping through companies as they work to adapt an industry 4.0 mindset into their operations while maintaining quality and compliance under an equally evolving FDA.
Insights to Impact is BioBuzz's highly curated event series in the BioHealth Capital Region exclusively for biopharma industry leaders and professionals. This is event #6 of 9.
Overview
Biopharma is being forced to rewrite its compliance playbook.
On one side, the FDA and EMA are signaling tougher enforcement with unannounced inspections and new initiatives like PreCheck to boost domestic manufacturing. On the other, companies are racing to adopt AI, machine learning, and digital twins to transform development and manufacturing — technologies that create massive opportunities but also new regulatory risk.
This exclusive panel brings together regulators, operators, and digital experts to explore what the next-generation quality and compliance playbook looks like — and how leaders can prepare their organizations to thrive in this disruptive new era.
The event will serve as a touchpoint for clients, consultants, investors, and partners to connect, celebrate the year, and engage in meaningful dialogue about these important trends.
Agenda + Speakers
4:00-4:45pm Check-In + Networking
4:45-4:50pm Welcome + Opening Remarks
4:50-5:50pm Panel Discussion
5:50-7:30pm Networking
Sponsors
About PQE Group
PQE Group is an ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle.
With offices located worldwide and a full-ranged broad service portfolio, extensive experience, effective project management, and exceptional cost effectiveness, PQE’s solutions are proven to be the winning combination for global corporations, as well as small and medium sized companies.
Learn more at pqegroup.com.
About AllSci
AllSci is an innovative startup revolutionizing the creation, publication, and consumption of scientific knowledge. AllSci’s platform allows researchers to publish all their ideas and experiments, explore the existing literature through novel and intuitive means, and get credit for their contributions to the scientific dialogue.
Learn more at allsci.com.
About Heffron Company
Heffron is a trusted and knowledgeable mechanical and plumbing installation company in the Washington, D.C. area with extensive experience designing, consulting, and installing a range of highly efficient systems.
For 103+ years, their multi-generational company, has been serving the BioHealth Capital Region in the following areas:
Plumbing and heating, ventilation, and air conditioning (HVAC)
Renovation and tenant services
Process-systems installation
Design/build contracting
Partnering and bridging coordination
Value engineering
Environmental remediation
Design review
Important Information
This event is FREE for industry leaders and professionals, providing a unique opportunity to gain insights on important industry trends and connect with fellow life science professionals, entrepreneurs, and advocates in a peer-oriented setting. Vendor and service provider attendance is paid and restricted to ensure a high-value program.
We encourage you to share this with those in your network who are passionate about strengthening the BioHealth Capital Region’s biotech ecosystem and would benefit from attending.
NOTE TO VENDORS + SERVICE PROVIDERS
Vendors that operate in the same category as any of our sponsors will be restricted from attendance unless pre-authorized by the associated sponsor. BioBuzz reserves the right to restrict registration and entry as we deem necessary. Refunds will be provided when tickets if/where necessary.