Confirmed speakers for 2012

The longest running European event devoted to cutting costs, increasing efficiency and improving quality through best practice PAT and QbD implementation.

Building on the previous successes of our PAT and QbD conferences, Pharma IQ is delighted to present its 9th Annual PAT and Quality by Design event to be held in London, February 2012. With an extensive agenda we provide a platform for knowledge acquisition, networking and first hand experience from fellow industry specialists and regulatory bodies.

As the demand for quality and efficiency intensifies year on year the need for measures such as PAT and QbD becomes more prominent. The constantly evolving landscape of the PAT and QbD industry sees an increased regulatory pressure to adopt these quality practices in line with producing high quality drug products at all times.

In view of this we are offering a unique opportunity to learn from leading PAT and QbD experts from the industry and hear from those all important regulators!

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FEATURED PODCAST: Making a Business Case for PAT and QbD Implementation

Brett

In this presentation Brett Cooper Research Fellow, MSD Development Laboratories, speaks to Andrea Charles from Pharma IQ, about the slower than anticipated industry uptake of PAT and QbD, the key benefits of PAT and QbD implementation and the biggest challenge pharma and bio companies face regarding the interpretation of regulatory guidance. Cooper also discusses how to prove the business case for PAT and QbD implementation

Listen now!

Key topics the event will discuss:

  • Key current regulatory updates, including the release of ICH Q11, and how to best interpret regulatory guidance
  • Best practice approaches to writing regulatory submissions
  • The practical advantages of PAT and QbD implementation and how to maximise the financial benefits
  • How PAT and QbD can be implemented from research and development through to manufacturing
  • Developing design spaces and overcoming the challenges presented along the way
  • Best practice approach to, and realising the benefits of, identifying your Target Product Profile from the offset
  • How best to overcome the challenges of implementing PAT for biologics
  • Assessing the framework for Quality Risk Management

5 Great Reasons to Attend

  1. Hear first hand from the regulators! Gain insightful knowledge on how to interpret regulatory guidance, understand best practice approaches to writing submissions and gain feedback directly from the SWISSMEDIC and BfArM on previous submissions
  2. Truly understand the benefits and ROI of QbD and learn how to successfully present QbD's business case to senior management with feedback from PHILIP MORRIS INTERNATIONAL
  3. Apply PAT to biologic manufacturing by understanding how to successfully use its tools and techniques in a biotechnology environment: GENZYME share their experience
  4. Create and effective quality risk framework with expert insight from PFIZER
  5. Discuss experiences, thoughts and feedback with leading industry speakers from NAPP PHARMACEUTICALS, PMI and STEP CHANGE PHARMA by participating in interactive round table discussions assessing the financial benefits of PAT and QbD, risk management guidelines and PAT and QbD in the biopharmaceutical field.

A few words from your speakers:

In my presentation I intend to share how Hovione, a Contract Manufacturing Organization (CMO), is pushing forward the QbD/PAT methodologies at a corporate level, along with some case studies, namely the example of a product already approved by the FDA. I also look forward to discussing the role of the CMO in the integration of QbD/PAT methodologies across the drug substance and drug product supply chain during development and commercial manufacturing.
Nuno Matos, PAT Specialist, Hovione
At the conference I will be talking about PAT and QbD within the early development space. This is becoming an increasingly important area of interest within MSD. Establishing the correct QbD strategies and tools early in the development process is key to ensuring we have robust quality products downstream.
Brett Cooper, Research Fellow, MSD Development Laboratories

Who will you meet?

  • Senior Technical Directors
  • Senior Heads of Quality Compliance
  • Process Development Scientists
  • Senior PAT and QbD specialists and experts
  • Project Managers
  • Senior Scientific Advisors and Inspectors
  • Senior Scientists

Keywords

  • Process Analytical Technology (PAT)
  • Quality by Design (QbD)
  • Design Space
  • Target Product Profile (TPP)
  • API
  • Critical Process Parameters
  • Quality Risk Management
  • Design of Experiments (DoE)
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