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Pharma

Cell & Gene Therapy Products – CMC & Quality Requirements
26 – 28 November 2025
Radisson Blu 1882 Hotel, Barcelona Sagrada Familia, Barcelona, Spain | Online Live Stream | 9:00 - 17:30
With the increasing complexity of new cell & gene therapies, as well as a rapid growth of these products in development, unique challenges have emerged especially in manufacturing and control.
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Pharma

Companion Diagnostics (CDx) - Navigating the Regulatory Challenges
3 – 4 December 2025
Renaissance Vienna Schönbrunn Hotel, Vienna, Austria
The implementation of the EU In Vitro Diagnostic Device Regulation 2017/746 (IVDR) has introduced new processes for the authorization of performance studies and conformity assessment of companion diagnostic devices (CDx) in Europe.
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Pharma

CMC Analytical Comparability: Methods & Strategies for Biologics
11 – 12 February 2026
Vienna, Austria | Online Live Stream | 9:00 CET – 17:30 CET
Join our CMC Analytical Comparability training led by experts to understand principles of protein structure and comparative analytics.
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Pharma

Pharma Laboratory Digitalization & Validation
4 – 5 March 2026
Vienna, Austria | Online Live Stream | 9:00 CET – 17:00 CET
The need for digitalization in the pharmaceutical laboratories is continuously evolving & there is a need for a more unified approach to laboratory and data management.
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Pharma

Extractables & Leachables Analysis
10 – 12 March 2026
Online Live Stream | 14:00 CET – 18:00 CET
Since its inception the topic of extractables and leachables has grown continuously. It has expanded into different dose forms and heighted regulatory expectations.
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Pharma

Pharmacovigilance for Animal Health Medicinal Products – Regulatory Frameworks and Signal Management
21 – 23 April 2026
Online Live Stream | 13:30 CEST – 17:30 CEST
This comprehensive training course addresses these critical challenges by bringing together leading pharmacovigilance experts and regulatory specialists who will demystify current regulatory requirements, share practical insights from frontline experience, and provide actionable guidance for compliance and excellence.
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Pharma

Digital Quality in Clinical Trials
22 – 23 April 2026
Vienna, Austria
With the increasing complexity of today’s clinical trials, as well as the speed of technological innovation and AI tools utilization, unique issues remain especially around clinical trials and the use of electronic systems.
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Pharma

Immunogenicity of Biologics, Biopharmaceuticals & ATMPs
28 – 29 April 2026
Online Live Stream | 13:00 CEST – 18:00 CEST
This unique course provides a practical & in-depth understanding of immunogenicity risk assessment and risk minimization.
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Pharma

Quality & Regulatory Requirements for Drug Device Combination Products in the EU
upon request
Online Live Stream
This course will cover the definition of combination products, EU regulatory pathways, and will explain the current state of developments as medical device manufacturers and marketing authorisation holders prepare for the new requirements.
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