Lance Smallshaw BSc(Hons) PhD EurChem CSci CChem FRSC, UCB Biopharma sprl. - Qepler Summits And Conferences

Lance Smallshaw BSc(Hons) PhD EurChem CSci CChem FRSC

Regulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia)
UCB Biopharma sprl.
Wallonia, Belgium
With a unique combination of expertise in biology and chemistry, UCB is a global biopharma focusing on severe diseases in two therapeutic areas – CNS and Immunology.

After completing nearly a total of 38 years at Eli Lilly and Company and UCB Biopharma sprl based in various international locations he has specialised in both biopharmaceutical / chemical analytical development and GMP QC.

Lance has been associated with numerous UK government new analytical technologies projects from routine testing to PAT and was a trainer in Statistical Process Control (SPC) for more than 15 years.

He was one of the original conception members of the European CMC Committee for CaSSS in Biopharmaceuticals.

He has more than a decades experience as trainer in Good Quality Control Laboratory Practice and in the associated Chapters / Annexes of the European GMP Guide for the European Qualified Person Association (EQPA) and in 2013 Lance was appointed to the Foundation Board of the European Compliance Association (ECA) and is currently their Co-Chairman.

In the past six years Lance has led the UCB Global team to define the strategy and to revise the compendial heavy metals test following ICH’s announcement to update the test using a risk based approach with the introduction of its Guideline on Elemental Impurities (ICH Q3D).

Lance is currently based in Belgium working in the UCB Corporate Analytical Sciences (CAS) team as Regulatory Intelligence and External Advocacy (Quality Analytical and Pharmacopoeia).

Related Sessions:

Genotoxic Impurities in
Pharmaceuticals Summit 2019

GTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
  • 11 Apr 2019
  • Berlin, DE
  • Pharma
Day 1: Thursday, 11 April 2019
CASE STUDY: What to do if you need to do to propose a regulatory change to a ICH Q3D Elemental Impurity Control Threshold or PDE Limit.
  • Examples of reports including toxicology assessment
  • Typical data with revised limit calculations
  • Example letter to the authorities to request the change
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