Connie Langer

Pfizer
Senior Director, Quality Regulatory Intelligence
Connie Langer is a Senior Director and leader of the Regulatory Intelligence Team within Pfizer Global Supply. This team assesses new and revised regulations and provides advice on implementation expectations to key stakeholders. Connie has extensive experience implementing science- and risk-based approaches and recommending strategic regulatory options to achieve product approvals globally. Connie is a member of the ISPE PQLI® ICH Q12 Working Team and chair of the IQ ICH Q12 Working Group. She holds BS in Chemical Engineering and an MS in Chemical Oceanography both from the University of Connecticut, and a Drug Development Certificate from Temple University.

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Reporting categories for changes in the drug substance (DS) and drug product (DP) process and analytical methods per FDA guidance [
Features
Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12

The latest ICH guideline, ICH Q12,1

  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019.
ICH Q12: A Transformational Product Life-Cycle Management Guideline
Features
ICH Q12: A Transformational Product Life-Cycle Management Guideline

On 20 November 2019, the ICH Assembly endorsed the Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” at its biannual meeting in Singapore. This transformational guideline has a wide scope of applicability across pharmaceutical drug substances and products (both chemical and biological), drug-device combination products that meet the...