Day two in focus: navigating regulatory strategy at The Future of Bio/Pharmaceutical Analysis 2026

When The Future of Bio/Pharmaceutical Analysis Virtual Summit moves into its second day on Wednesday 24 June 2026, the focus shifts to one of the most consequential and fast-moving areas in drug development and manufacturing: regulatory strategy. Three panel discussions, running back-to-back through the afternoon, take a hard look at the compliance and quality pressures that are reshaping how biopharma companies operate. From nitrosamine management to GLP-1 product quality, and from US agency dynamics to European regulatory reform, the day is designed for the professionals tasked with keeping pace with change while keeping product on the shelf. Here is what to expect from day two.

Lightening the nitrosamine load (12:00–13:15)

Day two opens with a session on nitrosamine impurities — an issue that has dogged pharma manufacturers for several years and shows no sign of fading from the regulatory agenda. Requirements for testing and control continue to evolve, and the growing number of products implicated by nitrosamine drug substance-related impurity (NDSRI) formation means that risk assessment, confirmatory testing and control strategy remain live concerns for a widening cross-section of the industry. The panel will cut through the complexity to address what manufacturers need to know and do right now, covering:

• An update on testing deadlines and requirements from the US Food and Drug Administration (FDA)

• Ensuring precise testing and comprehensive compliance

• Staffing for success and building the right cross-functional team.

With FDA deadlines continuing to concentrate minds, this session will offer practical guidance for organisations at any stage of their nitrosamine compliance journey, from those still mapping exposure to those refining established control strategies.

Quality control, and reference standards, in the GLP-1 era (13:30–14:45)

The second session takes on one of the most commercially significant challenges in contemporary pharmaceutical analysis: ensuring product quality in the GLP-1 drug class. What began as a diabetes treatment has become an industry-defining therapeutic category, with obesity indications driving extraordinary demand and a new wave of innovation — including small molecules and next-generation formulations — already in development. The pace and scale of that growth have placed real pressure on quality control functions, which must establish and maintain analytical accuracy for products whose complexity presents genuine technical challenges. The panel will explore how manufacturers can rise to that challenge, with discussion covering:

• Tackling the inherent complexity of GLP-1 products

• Following best practice in quality assessments

• Preparing for the next wave of GLP-1 innovation, from small molecules and beyond

For analytical scientists and QC leaders working in this space, the session offers a timely opportunity to benchmark current approaches and look ahead to the methodological and regulatory challenges that the next generation of GLP-1 therapies will bring.

Navigating regulatory change in the US and Europe (15:00–16:15)

Day two closes with a broader strategic lens on regulatory change, addressing the sweeping disruption that biopharma manufacturers are navigating on both sides of the Atlantic. In the US, agency dynamics and user fee negotiations are reshaping the relationship between industry and the FDA. In Europe, landmark legislative reform is recasting the competitive and regulatory landscape. The net effect for manufacturers is a period of significant uncertainty, in which long-standing frameworks are in flux and the next set of stable operating conditions remains unclear. This session will help participants orient themselves in that environment, focusing on:

• Preparing for the next generation of FDA user fee agreements

• Assessing European moves to increase the region’s competitiveness

• Seeking certainty amid continuous change.

With regulatory affairs professionals facing demands that span an increasingly complex global landscape, this session offers an essential briefing on where the major frameworks stand, where they are heading, and how organisations can build the responsiveness to adapt as the picture evolves.

What ties the day together

Running through all three sessions is a single organising tension: the regulatory environment is moving faster than many organisations were built to handle. Whether the challenge is the rolling complexity of nitrosamine compliance, the analytical demands of a fast-scaling new drug class, or the wider upheaval affecting agency relationships and legislative frameworks, the common requirement is the capacity to respond quickly, accurately and with the right people in the room. Day two’s panels draw on expertise from across global pharma, regulatory consultancies and standards bodies to provide that guidance in direct, practitioner-focused terms. Expect candid discussion of what is working, what is not and where the next pressure points are likely to emerge. The day sets a rigorous regulatory context for the rest of the summit, which moves into digital, AI and automation on day three.

Secure your place

Registration is complimentary but places are limited. Join regulatory affairs, quality control, analytical development and manufacturing leaders from across the global biopharma industry for three days of practical insight, peer debate and forward-looking strategy. Register now for The Future of Bio/Pharmaceutical Analysis 2026.