PharmaLab 2026: AQCG Organises Pre-Conference and APLM Track

PharmaLab 2026 will take place from 23 to 25 November 2026. This year, the event will move to a new venue: the darmstadtium – the Congress Center of Science City Darmstadt, located close to Frankfurt International Airport.

Benefit from 9 parallel conferences and 3 pre-conference workshops, featuring a total of over 130 presentations, around 60 exhibitors, and a networking event, to get your update on the following topics:
 
Pre-Conferences on 23 November:

• 7th International Mycoplasma qPCR Testing User Day
• Quality Control of mRNA/LNP Products
• Data Quality Management of Aberrant Results - Handling Out of Specification, OOS, and Out of Trend, OOT Results

PharmaLab on 24/25 November:

• Analytical Procedure Lifecycle Management (APLM)
• GMP Compliance Trends Analytical Laboratories
• Bioanalytical Control of Drug Substances and Drug Products
• Cell and Gene Therapies / ATMPs - Quality and Safety
• Bioassays/Potency Assays - Regulatory Requirements, Developments and Routine Use
• Endotoxin and Pyrogen Testing
• Alternative and Rapid Microbiological Methods
• Laboratory Optimization, Automation and Digitalization/Outsourcing in Pharmaceutical Laboratories
• Artificial Intelligence in Laboratories

This year, the ECA Analytical Quality Control Group (AQCG) will organise one of the pre-conference workshops and a dedicated one-day conference track on Analytical Procedure Lifecycle Management (APLM).

Data Quality Management of Aberrant Results

This pre-conference workshop on 23 November aims to strengthen participants’ capability to manage data quality and investigate aberrant results in pharmaceutical laboratories by:

• providing a structured approach to handling Out of Specification (OOS) and Out of Trend (OOT) results,
• explaining key regulatory and guidance expectations and how they translate into practical lab procedures,
• applying trend analysis tools and statistical rules to evaluate OOT signals – incl. understanding common pitfalls and misinterpretations – through an interactive Excel-based exercise.

Analytical Procedure Lifecycle Management (APLM)

This one-day track on 24 November aims to provide a lifecycle-based, risk-driven framework for developing, validating, and maintaining analytical procedures from early development through registration and post-approval change. Participants will learn how to apply current USP updates and use practical case studies (ATP, risk assessment, MODR, validation strategies, precision/replication, platform methods, and OPPV) to define fit-for-purpose validation scope, ensure method robustness and independence, and manage changes in an inspection- and dossier-ready way.

More details can be found on the PharmaLab website. The detailed program and agenda will be published in a few weeks.