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June 02, 2026
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A compliant and efficient EU–UK GMP–GDP supply chain requires a clear understanding of roles, responsibilities, and operational integration across importation, certification, and distribution activities. As organizations expand into European and UK markets, navigating the distinctions between Marketing Authorization Holders (MAH) and Manufacturing/Importation Authorization Holders (MIAH), as well as managing Qualified Person (QP) responsibilities and import testing requirements, becomes critical to ensuring timely and compliant product release.
April 23, 2026
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As cell and gene therapies transition from clinical development to commercialization, organizations face evolving regulatory expectations, expanded CMC requirements, and increased MAH responsibilities. This session examines common gaps between clinical and commercial operations, inspection readiness challenges, and quality system maturity. We will share practical strategies to strengthen manufacturing preparedness, align MAH and CMO roles, and build an integrated, risk-mitigated pathway to successful market authorization and sustained commercial supply.
April 09, 2026
As European Medicines Agency Policy 0070 enters its expanded Step 2 phase, sponsors face increased document volumes, heightened transparency obligations, and greater scrutiny of anonymization and CCI decisions. This session explores the realities of advanced Policy 0070 compliance, strategies to strengthen anonymization methodologies, and defensible CCI justifications. We’ll also examine common areas of challenge and rejection, highlight lessons learned from early submissions, and outline best practices for scaling processes, aligning cross-functional teams, and managing timelines under Step 2.
March 12, 2026
Uncover the intricacies of Pharmacovigilance System Master File (PSMF) management and explore proven strategies to ensure inspection readiness, effective MAH oversight, and regulatory compliance across global PV systems. Our expert will share practical tips and lessons learned from supporting MAHs, LPPVs, and QPPVs through successful inspections. We'll address real-world inspection findings, highlight best practices for PSMF governance and oversight, and take questions from the audience, allowing you to focus the discussion on what you need to know to maintain an accurate, inspection-ready PSMF and demonstrate robust oversight of your PV system.
February 17, 2026
With promotional scrutiny increasing around areas such as social media, influencer campaigns, direct-to-consumer (DTC) messaging, and data-driven claims, the session walks through the characteristics of an effective, high-performing MLR committee and explores how cross-functional teams can collaborate strategically to assess risk, interpret evidence, and support business objectives. Join us to explore practical insights on defining roles, aligning perspectives across medical, legal, and regulatory functions, and applying best practices to navigate evolving agency expectations while maintaining compliance and enabling innovation.
February 11, 2026
Navigate the complexities of offshoring Medical Information and explore proven strategies to ensure consistent quality, regulatory compliance, and seamless global execution. Join us for an interactive webinar where our Medical Information leaders and quality experts will share practical tips and lessons learned from successfully establishing and managing offshore MI operations. During the session, they will address real-world challenges, highlight best practices for governance and oversight, and take live questions from the audience—allowing you to focus the discussion on what you need to know to build a scalable, high-performing, and compliant global MI model.
January 20, 2026
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In this power-packed webinar, we’ll demystify technology transfer and show why it’s one of the most strategic and risk-sensitive steps in pharmaceutical and biotech operations. You’ll uncover insider strategies for navigating complex CDMO partnerships, avoiding costly pitfalls, and mastering best practices that ensure flawless execution and regulatory alignment.
November 18, 2025
Explore how the new EU HTA Regulation (EU HTAR) is transforming market access across Europe. Join our expert to learn practical strategies for successful Joint Clinical Assessment (JCA) submissions, evidence planning, and navigating the evolving HTA landscape with confidence.
November 11, 2025
Navigate the complexities of EU marketing authorization to explore tips for successful Marketing Authorization Application (MAA) submissions in Europe to ensure proven strategies, reduced delays, and approval success. Bring your questions and join us for an interactive webinar where our team of regulatory experts will provide tips and tricks for successful regulatory applications based on their extensive experience preparing and submitting MAA submissions. During this session they will also take live questions from the audience, allowing them to guide the discussion around what you need to know to increase your chances of success with the regulators.
October 16, 2025
In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what role do regulatory authorities play in shaping the safe adoption of AI? This webinar will explore the evolving responsibilities tied to AI in the workplace. Through real-world examples from both general applications and in MI, we’ll highlight opportunities, risks, and current regulatory considerations.
September 25, 2025
Medical Information (MI) and Pharmacovigilance (PV) work together to protect public health by identifying and evaluating emerging safety signals. Watch our in-depth webinar, where our experts explore how MI and PV maximize patient safety, with practical guidance, real-world examples, and perspectives from both disciplines.
September 23, 2025
Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and compliance risk. How can teams streamline these meetings to ensure faster approvals without compromising regulatory standards? Discover how to run faster, more effective MLR review meetings without sacrificing compliance. Join us to learn practical strategies to streamline promotional review and accelerate approvals.
September 17, 2025
In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards, governance frameworks, and integration strategies can turn siloed information into actionable intelligence. Learn to build FAIR-compliant ecosystems, enable AI-readiness, and harmonize legacy and modern systems. Gain practical insights into embedding standards into workflows, fostering collaboration, and driving digital transformation to accelerate discovery and sustain long-term innovation.
September 10, 2025
In the face of proposed US tariffs on foreign pharmaceutical products—including APIs, excipients, drug substances, and drug products—critical decisions loom: Should companies maintain current supply chains, build inventory, acquire domestic manufacturing, partner with a CMO, expand US operations, or seek preferred nation alternatives? And how can leaders balance business goals with patient access if passing costs to patients proves unsustainable? This webinar examines the latest tariff status and timelines, presents data-driven analysis of strategic options, and outlines practical steps to align decisions with implementation deadlines, helping you validate your strategy or create a robust tariff contingency plan.
July 29, 2025
Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert guidance from our experts. Beginning August 2025, FDA inspections at non-U.S. manufacturing sites will occur without prior notice, requiring continuous inspection readiness. This webinar, led by ProPharma’s inspection readiness experts, will explore what it means to be truly inspection ready and highlight common issues found during FDA inspections—helping your organization stay compliant and prepared.
July 22, 2025
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Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand knowledge of the Agency’s review process, he’ll walk through the most common deficiencies that lead to review delays and discuss how to avoid them. From strategic labeling decisions tied to patents and exclusivities to submission formatting and data integrity, this session will provide practical guidance to help applicants craft a more efficient, quality, and approvable ANDA.
July 10, 2025
This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and strategies for successful market access—from initial authorization to product launch. Ideal for regulatory, PV, clinical, and commercial professionals.
June 03, 2025
This webinar will explore the strategies and best practices for establishing a cost-effective global Medical Information (MI) contact center. Attendees will learn how to ensure local market buy-in, achieve complete market coverage, and measure customer satisfaction to ensure the health and safety of patients.
May 22, 2025
Under EMA Policy 0070, sponsors are mandated to submit anonymized clinical reports for publication on the Clinical Data Publication (CDP) portal, where they can be accessed by external researchers. Discover best practices for meeting EMA Policy 0070 requirements efficiently and effectively
April 29, 2025
Unpack the latest regulatory trends, FDA expectations, and compliance strategies for medical device software, IVDs, and AI-driven technologies—gain real-world insights to accelerate development and de-risk your path to market.
April 10, 2025
We’ll dive into how AI can reduce errors, save time, and enhance accuracy in listings and summary tabulations. But what about the challenges? From software costs to data security risks and programming limitations, we’ll address the key considerations for implementing AI in PV.
November 19, 2024
Discover strategies to transition Phase III clinical trial patients to commercial products, while ensuring accessibility, affordability, and compliance.
October 22, 2024
Learn strategies for assessing and filing post-approval changes in small molecule products while ensuring regulatory compliance.
June 20, 2024
An essential guide to PV system implementation in the UK and EU/EEA.
April 24, 2024
Learn to identify and mitigate risks in vendor relationships with confidence.
April 18, 2024
Leveraging AI to de-risk Pharmaceutical, Biotech, and Medical Device programs and maximize success. Learn how generative AI applied to massive data can optimize product development end-to-end.
September 28, 2023
Gain insights on the current opportunities that can simplify the path to ATMP development including, decentralised manufacturing, utilizing the hospital exemption in the EU, early integration of devices and diagnostics into the overall development plan, and addressing the growing demand for comparative results from stakeholders in drug development.
September 20, 2023
How life science companies can realize the full value of their R&D data.
July 11, 2023
Navigating regulatory challenges, optimizing protocols and breaking access barriers.
April 18, 2023
Learn how to showcase your product in the best scientific light, optimize statistical processes, animal models, and pharmacodynamics for better results.