Brochure and Registration

Click on the picture to open the complete programme as PDF.

To book this conference, please click on one of the following links:

- EU GMP Inspectorates (EUR 945) per delegate plus VAT
- ECA Members (EUR 1.690) per delegate plus VAT
- APIC Members (EUR 1.790) per delegate plus VAT
- Non-ECA Members (EUR 1.890) per delegate plus VAT

PAT / QbD – Reflections on the first 10 Years

  • 10 years ago regulatory uncertainty and ‘don’t use or don’t tell’ approach to adaption of new analytical and process control technology
  • PAT Guidance – a different; unusual guidance. Some ‘loved it’ some didn’t – why?
  • PAT Team Approach to facilitate innovation and continual improvement – what can we learn from this experience?
  • Current state of PAT & QbD implementation and regulatory challenges in the US and globally.
  • Current FDA efforts and how the PAT Guidance/Team approach can inform these efforts
  • Going forward – ensuring data integrity and continued process verification – how to be prepared?
Dr Ajaz Hussain, Insight Advice & Solutions LLC, USA

Analytical Methods and Sampling in the New Manufacturing Paradigm – a Regulatory Perspective
  • Demonstrating end-product quality by on-line (PAT) measurements
  • Ph.Eur. 2.9.47: Uniformity of dosage units using large sample sizes
  • Analytics based on libraries/ calibration models: pitfalls and opportunities
  • Real time release testing: general considerations

Dr Øyvind Holte, Norwegian Medicines Agency/ EDQM PAT working party/ EMA PAT team

Continuous Manufacturing of Small Molecule APIs

  • Process Understanding and Process Control: "understanding" a process means having a science-based process model (as opposed to a phenomenological description) and using this model to "control" the process both to keep it within the design space and to allow for continuous improvement.
  • Regulatory Aspects: covers items such as definition of batch / lot etc., but also how to take the step from a control strategy based on analysis of batches to a control strategy for manufacturing processes consisting of a mix of batch and continuous steps.
  • Business Aspect:
    - fields of activities where the changeover to continuous manufacturing has proven to be profitable 
    - drivers to select a continuous manufacturing option 
    - key success factors in implementing a continuous process.

Dr Peter Poechlauer, DSM

Case Study 1: The Evolution of Material Sciences as a Key Contributor to Determining the Critical Attributes of Active Pharmaceutical Ingredients (APIs)

  • Understanding the key material science methodologies deployed to fully understand active pharmaceutical ingredients from the molecular to bulk powder attributes.
  • Case studies will be shared where these methods have enabled understanding of the critical attributes of an API which influence its subsequent behaviour in the final drug product.
Fiona Clarke, Pfizer Ltd., Sandwich, Kent

Case Study 2: The Impact of Material Science in Increasing Understanding of Drug Product Performance and Manufacturability
  • Overview of the suite of material characterisation tools which can be utilised to evaluate a range of drug product platforms (incl. solid oral dose and aseptic)
  • Providing real examples of where through the understanding of material physical attributes it is possible to drive to full understanding of product performance.
Fiona Clarke, Pfizer Ltd., Sandwich, Kent

Case Study 3 - Quality by Design in Action:
Improving Product Quality by the Transformational Use of Process Understanding in Design, Development, and Commercial Supply
  • Use of combined modelling approach in a systematic development of product & process for an oral solid dose product
  • Product quality is a direct function of formulation, excipients, and the process of manufacture
  • The manufacturing process must repeatedly deliver required product to the “performance” specification
  • Process measurement, control and monitoring are critical aspects to provide a sustainable supply of product to patient.
Sander van den Ban, GSK, UK

Case Study 4 – Understanding Process Dynamics: the Route to Continuous Improvement
Dr Peter McDonnell, Sanofi, France

Case Study 5 – The application of PAT to complex molecules synthesis
Dr Peter McDonnell, Sanofi, France

Bioequivalence – Still a Quality Achilles Heel?
  • Pharmaceutical equivalence & Bioequivalence: a quick historical perspective
  • What has worked and what needs to be improved: Complex physical attributes, approval of complex generic and new drugs
  • Waiver of bioequivalence – based on in vitro characterization. A case example: In vitro dissolution
  • Bioequivalence considerations during continual improvement and post-approval changes
  • Specifications for critical physical attributes and bioavailability/bioequivalence: key considerations
Dr Ajaz Hussain, Insight Advice & Solutions LLC, USA

PAT in Action:
a Lifecycle Approach to Applied Process Understanding

- A Lifecycle Approach to Applied Process Understanding to set meaningful process and product specifications combining:
  • Pharmaceutical science
  • Materials science
  • Chemical process engineering science
  • Measurement science
Sander van den Ban, GSK, UK

Case Study 6: The Development and Implementation of a Continuous Drug Product Manufacturing Process – The Process, Control, Regulatory and Cultural Change
  • From a vision to a qualified system
  • Integrating the systems and the people
  • Developing process knowledge in continuous manufacturing
  • Building an analytical organization to support continuous processing

Justin Pritchard, Vertex, USA

Compliance Enforcement Action Items

  • Update on recent FDA Warning Letter, Untitled Letter, 483 notice of observations, and correspondences related to acceptance criteria
  • These examples cover expectations and issues related to Current Good Manufacturing Practices (CFR 210,211) and use of statistics Dr Karthik Iyer FDA /CDER (via video conference) REGULATORY CGMP Statistics – Process Capability Enforcement Actions

Karthik Iyer FDA /CDER (via video conference)

Case Study 7: Moving PAT from “Nice to Have” to a Reliable Measure of Product Quality

  • Committing to Real Time Release testing and in-process controls using process analysis technology
  • Material planning to enable PAT implementation from day 1
  • Lessons learned from developing chemometric models
  • Delivering results: Building confidence with data and protocol driven activities
Justin Pritchard, Vertex, USA

CGMP Statistics - Process Capability Enforcement Actions
  • Process Capability
  • Use of consensus standards
  • Example of a Warning Letter related to use of process capability
Karthik Iyer FDA /CDER (via video conference)