Speaker Points – Nordic QAforum 2024

Moderator: Karolina Nordin
Opens and concludes the conference.

Anna Berg, AstraZeneca

Topic: Roles and responsibilities between MAH and manufacturers
An overview of the main regulatory frameworks governing MAHs and manufacturers, including EU directives and national requirements. Focus on EU-specific responsibilities, practical examples, and best practices in role distribution.

Kristina von Sydow, e-Verifikation Sverige (E-vis)

Topic: 5 practical tips for improving e-verification quality
A review of recent changes in the European e-verification landscape (e.g. UK/Northern Ireland leaving, Greece joining). Insights into practical improvements in e-verification processes relevant to Sweden.

Nina Taher Nasabi & Marc Sommar, Roche

Topic: Temperature deviations – Quality and safety in focus
Analysis of how temperature deviations affect product quality and patient safety. Discussion of case handling, process improvement, and quality assurance measures.

Stefan Ernback, Sobi

Topic: Challenges and solutions for QPs in global supply chains
Insights into the Qualified Person (QP) role in a virtual, international environment, and strategies for ensuring compliance across complex supply chains.

Katarina Grip

Topic: Integrity and innovation – AI and computerized systems
With over 15 years in the pharmaceutical industry, Katarina shares her expertise on computerized systems and how AI is transforming quality and compliance work.

Panel discussion: Shortage Prevention Plan

Topic: Designing effective Shortage Prevention Plans
Open discussion with practical examples, challenges, and solutions. Participants shared insights on how to meet regulatory expectations and prevent drug shortages.

Samuel Fransson, Swedish MPA (Läkemedelsverket)

Topic: AI at the Swedish Medical Products Agency
How the agency uses AI to enhance efficiency and effectiveness in regulatory processes.

Emil Schwan, Swedish MPA (Läkemedelsverket)

Topic: Updates in GMP and GDP
News and practical tips: How to turn inspection deviations into improvements. Includes a Q&A session with the audience.

A Leading Pharmaceutical Conference on Quality Assurance in the Nordics

Nordic QAforum 2025 once again solidified its reputation as the premier pharmaceutical QA event in the region. With participants from top-tier pharmaceutical companies, national authorities, and regulatory agencies, this year’s conference delivered critical insights into the future of quality assurance, compliance, and innovation in pharma.

🔎 Regulatory Inspections & Risk-Based Oversight

Regulatory agencies from across the Nordics – including the Finnish, Norwegian, Danish, Icelandic, and Swedish Medicines Agencies – shared the latest insights from GMP/GDP inspections.
Attendees gained:

• First-hand accounts of unexpected findings, recurring deviations, and how to align with inspection expectations.

• Best practices for managing laboratory control issues and temperature-sensitive product returns.

• A deep dive into national and EU-level regulatory developments affecting MAHs, affiliates, and supply chains.

🧠 Expert Insights from the Industry

Top pharmaceutical companies presented strategic and operational insights:

• AstraZeneca explored ICH Q12 and Drug Shortage Prevention, offering concrete frameworks for life cycle management.

• Sobi and Novo Nordisk tackled global QA oversight and supply chain integrity, focusing on secure returns and destruction to prevent counterfeiting.

• Roche presented real-world QA challenges in handling temperature deviations and protecting product integrity.

🤖 AI & Digitalization in Pharma QA

With the accelerating role of digital technologies, speakers highlighted:

• Swedish Medical Products Agency (MPA) outlined current GMP and regulatory updates involving digitalization and compliance.

• AI applications in QA were a major talking point, both from industry (e.g. AstraZeneca) and regulators, focusing on predictive tools, automation, and compliance innovation.

📦 Drug Shortages, E-verification & Compliance Strategies

Presentations and discussions centered on:

• Drug shortages – challenges and guidelines for reporting across authorities.

• E-verification strategies – developments in the EU landscape, including the inclusion of new member states and implications for Sweden.

• Shortage Prevention Plans – expectations and implementation guidance for MAHs to prevent supply disruption.

💬 Interactive Discussions & Cross-Nordic Collaboration

This year’s program emphasized knowledge exchange and open dialogue, offering:

• Multiple Q&A sessions, with opportunities for attendees to pose real-world scenarios to regulators and QA experts.

• Networking breaks and a closing mingle session to foster relationships across industry and authority participants.

💡 A Conference that Shapes the Future of QA

From regulatory strategy to technological transformation, Nordic QAforum 2025 provided a roadmap for navigating tomorrow’s QA landscape in the pharmaceutical sector. Attendees left with actionable insights, strengthened networks, and inspiration to drive compliance and innovation forward in their organizations.

Whether you’re a seasoned professional or new to the field, the Nordic QAforum offers valuable opportunities to enhance your skills and network with peers who are equally passionate about quality assurance. If you are looking for a pharmaceutical conference is this the nordics top choice.

“This forum is a must-attend for anyone serious about Quality Assurance. The knowledge shared here is unparalleled.”

As industries evolve, quality assurance (QA) must also adapt to new technologies, regulations, and challenges. At Nordic QAforum, industry leaders discuss emerging trends that are shaping the future of quality control, regulatory compliance, and risk management.

1. Artificial Intelligence & Automation in QA

The integration of AI-driven analytics, automated compliance tracking, and predictive quality control is transforming pharmaceutical quality assurance. In the coming years, machine learning algorithms will enhance real-time data monitoring, ensuring faster issue detection and resolution.

💡 Example: AI-powered automated inspections are already reducing human error in pharmaceutical manufacturing, ensuring consistent GMP compliance.

2. Blockchain for Data Integrity & Traceability

With growing concerns about data integrity and cybersecurity, many organizations are exploring blockchain technology to ensure tamper-proof records in quality management systems.

🔗 How It Works: Blockchain allows for transparent, immutable documentation of compliance records, which is particularly useful in pharmaceutical supply chain management.

3. The Rise of Sustainability in Quality Assurance

Sustainability is no longer just a trend – it’s a necessity. Companies are shifting towards eco-friendly QA processes, including green manufacturing, waste reduction, and energy-efficient production.

🌱 Future Outlook: Regulatory bodies are introducing new sustainability compliance requirements, making environmental responsibility an essential part of quality assurance programs.

4. Enhanced Risk Management & Predictive Analytics

Instead of reacting to compliance failures, companies are implementing predictive risk management strategies to prevent quality issues before they occur.

📊 Why It Matters: AI-driven analytics and big data help identify patterns and predict potential compliance risks, improving overall product safety and efficiency.

5. Remote & Digital Auditing in a Post-Pandemic World

The shift to remote work and digital operations has led to a rise in virtual audits and cloud-based compliance management systems.

💻 Future Potential: More companies are investing in real-time digital audits to ensure continuous compliance, even in remote settings.

Preparing for the Future of QA

The future of quality assurance will be data-driven, AI-powered, and more globally interconnected than ever before. Attending forums like Nordic QAforum and QAforum Sweden ensures that QA professionals stay ahead of these changes and lead the way in compliance, risk management, and innovation.

🔎 Want to stay updated on the latest trends? Join us at the next Nordic QAforum and QAforum Sweden to gain expert insights and hands-on experience with the latest advancements in quality assurance.

1. What is Nordic QAforum?

Nordic QAforum is the leading quality assurance forum in the Nordic region, bringing together industry experts, researchers, and professionals to discuss best practices, regulatory updates, and emerging trends in quality assurance. The event features keynote speakers, workshops, and networking opportunities, making it an essential conference for those working in quality control, pharmaceutical compliance, and risk management.

2. Where and when does Nordic QAforum take place?

Nordic QAforum is held annually in Denmark. The exact date and location vary each year, and updates are provided on our official website.

3. What is QAforum Sweden?

QAforum Sweden is a separate forum based in Stockholm, Sweden, dedicated to Swedish quality assurance professionals. It provides insights into local regulations, industry developments, and networking opportunities, helping companies comply with Swedish and European quality standards. Learn more at QAforum.se.

4. Who should attend Nordic QAforum?

The event is designed for:
✔️ Quality assurance professionals in pharmaceuticals, biotech, and manufacturing
✔️ Regulatory compliance specialists and GMP/GDP experts
✔️ Auditors, inspectors, and consultants
✔️ Decision-makers and leaders in QA and supply chain management

5. How can I register for Nordic QAforum or QAforum Sweden?

You can register through our official websites:
🔹 Nordic QAforum: Visit nordicqaforum.com
🔹 QAforum Sweden: Visit QAforum.se

6. What topics are covered at Nordic QAforum?

Each year, we cover essential topics, including:
📌 Regulatory compliance (GMP, GDP, FDA & EMA guidelines)
📌 Risk management & auditing best practices
📌 Pharmaceutical research & innovation
📌 AI, automation, and digital transformation in QA
📌 Sustainability in quality assurance

7. Are there networking opportunities?

Yes! Nordic QAforum and QAforum Sweden both provide excellent networking opportunities, allowing professionals to connect, exchange ideas, and build industry partnerships.