GCP Inspection Readiness Forum


Brussels, Belgium

Your Journey to Becoming Inspection Ready

It is well known that building and maintaining a culture of quality is crucial to the success of a clinical trial, but how can you be sure that your methods are best practice?

The GCP Inspection Readiness forum will guide you on your journey to becoming inspection ready. Join like minded peers as you engage in high levels of interactivity and overcome your challenges in: creating a culture of quality, sponsor oversight, CAPAs, QMS and understanding the regulatory landscape. Complete your journey with our onsite mock-inspection where you will give your new skills a trial run and leave with the confidence, you are inspection ready.

As the only European forum where Clinical Quality and Operations Professionals join together in collaboration to benchmark with their peers in Big Pharma, SMEs and CROs, the GCP Inspection Readiness forum will give you the practical solutions you have been looking for.

Your Complete Journey to Inspection Readiness

  • Manage Inspector Expectations by Understanding Global Regulations, with insights from bluebird bio, Johnson & Johnson and Smith & Nephew.
  • Perfect your risk management strategy with case studies from Pfizer, Pierre Fabre and UCB
  • Streamline your approach to Good Clinical Practice by ensuring your electronic systems are up to scratch, as Grunenthal and Ferring give you their top tips
  • Re-imagine your strategy for sponsor oversight and transform the collaborative relationship, by hearing directly from PPD and Polpharma on how they maintain transparency and take ownership of quality
  • Safeguard your clinical trial by understanding the principles of data integrity with expert guidance from the Good Clinical Practice Alliance and the Health Sciences Records and Archives Association
  • Finish Point: All-Day Mock Inspection: Put your new skills to the test and leave with the confidence you ARE inspection ready! Exploring the latest case studies from Roche and Grunenthal

Our 2019 Speakers

  • Marie-Christine Poisson-Carvajal, Head of TMF & Registry Operations, Clinical Development Quality, Global Product Development, Pfizer
  • Mary MacDonald, Sr Auditor, Quality Assurance, bluebird bio
  • Patricia Giraldo, Quality Planning & Strategy (QP&S) Trial Oversight Specialist. Johnson & Johnson and (Former Scientific Officer at EMA Inspection Sector), Johnson & Johnson
  • Eldin Rammell, Chairman of the Board of Directors, HSRAA
  • Edyta Zbirog-Lukawska, Central Europe Quality And Compliance Adviser (Affiliate Process and Training Adviser), Roche
  • Caroline Sandstrom, Director GCP Compliance, Global QA, Development, Ferring Pharmaceuticals
  • Jurgen Lissens, Director Regional Compliance, Bristol-Myers Squibb
  • Alison Messom, Chairman of the Board of Directors, Institute of Clinical Research
  • Robrecht Tistaert, Senior Director Quality Strategy, PPD
  • Elke Ufer, Global GxP QMS Manager, Global Quality Assurance, Grunenthal
  • Franck Gressier, Head Clinical Quality Assurance, Pierre Fabre
  • Marie Boireaud, Clinical Quality Auditor, Pierre Fabre
  • Francis Crawley, Executive Director, Good Clinical Practice Alliance - Europe (GCPA)
  • Milos Stojkovic, Senior Safety Specialist, Global Medical Affairs, Clinical, Scientific & Medical Affairs, Global R&D, Smith & Nephew
  • Norbert Dank, Clinical Risk Management Lead , UCB
  • Tomasz Kosieradzki, Quality Assurance Advisor, Polpharma Biologics
  • Hobson Lopes, Manager, Clinical Archive Management, Clinical Document Management Group | Global Clinical Operations, REGENERON
Training Day - 16th September 2019

Conference Day One - 17th September 2019

Conference Day Two
- 18th September 2019

Workshop Day - 19th September 2019

Venue

Pullman Brussels Centre Midi Hotel
Place Victor Horta 1
1060 Bruxelles, Brussels
Belgium
Website: https://www.accorhotels.com/gb/hotel-7431-pullman-brussels-centre-midi/index.shtml
Phone: +32 2 528 98 00

Accommodation
Travel and accommodation are not included in the conference fee; however we have put together a HotelMap that displays discounted accommodation for hotels in the area near to Trial Master File and Inspection Readiness 2019. The map displays live availability and allows you to book directly with each hotel: https://www.HotelMap.com/pro/MULY4

Please note: We will never recommend, approve or appoint any third party rooming service to act on our behalf. Please be extremely wary if you are approached by any such companies. We will always endeavour to negotiate the best available rates for you so please use the HotelMap link provided; this shows live availability and rates for all hotels in the area and allows you to book directly with the hotel of your choice within your budget.