Mød underviserne på Navigating Drug–Device Combination Products (CP’s)

Javad Jabbari

Director Global Regulatory Affairs Device at Ascendis Pharma

Javad has background in R&D, QA and RA specializing in medical devices and combination products. He brings hands-on expertise in combination product regulatory strategy, combination product risk management, and implementation of Essential Drug Delivery Outputs (EDDO) in regulator-defensible development and lifecycle execution. JJ is an active speaker at international industry conferences, translating evolving expectations into practical, audit-ready approaches for cross-functional teams. He also serves as Chairman of Medicoindustrien’s Drug–Device Combination Product Expert Group, supporting industry alignment and best practices across the sector.

Casper Folsing

Director Global Regulatory Affairs CMC at Ascendis Pharma

Casper Folsing is a Director of Global Regulatory Affairs CMC with broad experience in regulatory strategy, CMC submissions, and lifecycle management for small‑molecule pharmaceutical products and biologics. He specializes in major variations, post‑approval changes, and global regulatory coordination across established and emerging markets, working closely with CMC, Quality, and manufacturing partners to deliver compliant and efficient regulatory outcomes.

Morten Purup Andersen

Sr. Human Factors Specialist at MGS Design & Development

Morten is a Senior Human Factors Specialist at MGD Design & Development. He teams up with clients ensuring that their human factors engineering (HFE) approach and data comply with applicable regulatory expectations. Further, he represents manufacturers in discussions with FDA and notified bodies. Morten is well-versed in all phases of HFE and is always on top of new regulations, guidance, standards, and their interpretation by health authorities.

In 2018, Morten co-initiated Medicoindustrien’s Usability Engineering expert group. Additionally, since 2020, he teaches IDA’s Medical Device Usability Engineering course.

Claus Rømer Andersen

CEO, Technical Advisor at Rømer Consulting

Claus is a freelance consultant at Rømer Consulting ApS specializing in design control, risk management, quality management, and safety for medical devices. He brings over 20 years of experience across test laboratories, device and drug manufacturers, standardization, and consultancy, with deep expertise in electrical medical devices. Claus works extensively with EU MDR, FDA QMSR (21 CFR Part 820), ISO 13485, ISO 14971, and the IEC 60601 series. He is convenor of IEC TC 62A WG47 and a contributor to IEC 60601-1 and IEC 60601-1-2, known for a pragmatic, solution-oriented approach.

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Anja Skands

Vice President, Drug Product and Device Development, CMC at Hemab ApS

More than 20 years of experience in the biotechnology industry across early- and late-stage process development with a focus on protein and peptide combination product development. Has worked on programs through early development, Process Performance Qualification, submission and regulatory approval by EMA, FDA and PMDA. Has a strong focus on using the principles from ICH to develop the drug products (ICH Q8) including a risk based approach (ICHQ9).

Haya NH Pedersen

Clinical Development & Clinical Evaluation Expert at MedEvi Consulting

Haya is a clinical development professional with experience across medical devices and drug–device combination products in EU and US regulatory contexts. She has held responsibility for clinical development activities and clinical documentation across product portfolios and lifecycle phases, including clinical evaluations, validation activities, and post-market clinical follow-up. In parallel, she works through MedEvi Consulting, supporting medical device companies on a freelance basis with framing and bridging scientific and clinical strategy to meet regulatory expectations and enable real-world use.

Rie Selchau Kallerup

Senior Manager, QA Commercial Drug Product & Finished Goods, Ascendis Pharma

Rie Selchau Kallerup is a senior quality professional with more than 15 years of experience within the biopharmaceutical industry. Rie holds a senior management position in Quality Assurance (QA) with primary responsibility for quality systems and quality oversight related to release of combination products.

Ries professional experience includes extensive work with Quality Management Systems (QMS), with involvement in the governance and application of core quality processes, including deviation management, change control, corrective and preventive actions (CAPA), risk management, and supplier qualification. She has acted as a Qualified Person (QP) for both drug substance and drug product within industrial as well as public-sector organizations.

Rie’s professional focus is on interpretation and practical application of regulatory requirements across integrated quality systems.

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