Lifecycle Management of Impurities - From Development to Market
An ECA Course prior to the 29th APIC/CEFIC Global GMP & Regulatory API Conference
20 October 2026, Copenhagen, Denmark
Course No. 22578
Speakers
Dr Ulrich Rose
Straßburg
Marieke van Dalen
MARA Consultancy
Target Group
This ECA course is designed for all persons involved in the manufacture of APIs, especially for persons from production, quality control, quality assurance, technical and regulatory affairs departments. We are also addressing interested parties from the pharmaceutical industry as well as GMP inspectorates.
Objectives
This ECA course provides an overview of the EU Pharmaceutical Legislation Reform and its impact on the API industry – from a regulatory and GMP point of view. During interactive sessions you will get to know:
Which GMP and regulatory aspects have to be considered to successfully submit a change
How to introduce a new intermediate manufacturer
How to deal with a new impurity in your API and what actions have to be taken
How to define critical quality attributes, critical process parameters, critical material attributes and an accurate control strategy
Furthermore, you will have the opportunity to reach clarification on ambiguous issues by bringing your questions up for discussion during the so-called break-out sessions.
This ECA course ideally complements the following 28th APIC/CEFIC Global GMP & Regulatory API Conference.
Programme
An Overview of the EU Pharmaceutical Legislation Reform
Background of the revision
Key elements of the proposal
Important Changes for the API industry
the revision of the variations guideline
the introduction of the API certificate
Handling Revisions of CEPs at EDQM
Impact of the EU guideline on classification of variations on the EDQM guideline for revisions of CEPs
Key aspects to submit successfully a change
API Changes: Validation and Implementation
Defining critical quality attributes, critical process parameters, critical material attributes and accurate control strategy
Eudralex Vol 4 Annex 15 on process validation
Implementation steps and performance monitoring
Use PV and scientific knowledge to implement Lean GMP Systems
Case Studies
Introduction of a new Intermediate Manufacturer
What to do in house: how to validate this change?
What regulatory actions to take?
Finding a new Impurity in your API
What to do in house: how to qualify this impurity?
What regulatory actions to take?
Further Information
Date ECA course
Tuesday, 21 October 2025, 09.30 - 17.15 h (Registration and coffee 09.00 - 09.30 h)
All times mentioned are CEST.
Venue
Barceló Sants Hotel Plaça dels Països Catalans, s/n 08014 Barcelona Spain Phone: +34 (93) 503 53 00 sants@barcelo.com
Date & Time
The API world is changing rapidly. Nowadays, changes are a daily business in the API industry. Companies are struggling with the challenge of how to implement the new regulations and requirements caused by e.g. reforms of the guidelines. To ensure the quality of their products throughout their life cycles, API changes need to be validated, submitted and implemented successfully. On the one hand, the theoretical obligations need to be considered and well known, while on the other hand the practical implementation needs to be beneficial and manageable in day-to-day API work.
Hot topics are presented in three lectures and two case studies. Additionally, you will have the chance to discuss your own topics with the speakers during the break-out sessions. Besides explaining the requirements of the guidelines of e.g. the revised variations guideline, for the respective themes, the speakers will share their approaches, experiences and best practices on these API related quality and regulatory Topics.
Testimonials
