IG Leaders

Ruhi Ahmed, PhD

• Regulatory Affairs

Maria Amaya, Roche

• Management on Outsourced Operations

Henry Ames

• Supply Chain Management

Arielle Anahory

• 503B Compounding

Marcia Baroni

• Annex 1 Implementation

Amanda Bishop McFarland, M.S.

• Quality Risk Management

Rebecca Brewer, Quality Executive Partners

• Annex 1 Implementation
• Sterile Processing/Parenteral Drug Manufacturing

Anthony Cannon

• Lyophilization

Paolo Curto

• Pharmaceutical Water Systems

Robert Dream

• Process Validation

Mirko Gabriele, PhD

• Technology Transfer

Mauro Giusti, PhD

• Process Validation

Gabriele Gori, PDA SAB

• Annex 1 Implementation
• GXP Auditing and Inspections

Igor Gorsky

• Pharmaceutical Water Systems

Ghada Haddad, PhD

• GXP Auditing and Inspections
• Quality Systems

Jane Halpern, PhD

• Vaccines

Olivia Henderson, PhD

• Pre-Filled Syringe

Kir Henrici

• Data Governance, Management, Integrity, and Digitalization

Kurt Jaecques

• Microbiology/Environmental Monitoring

Rebecca Jordan

• ATMP

Maik Jornitz

• Filtration

Hirohito Katayama

• Visual Inspection of Parenterals

Ulrich Kollisch

• Data Governance, Management, Integrity, and Digitalization

Beth Kramer

• Technology Transfer

Stephen Langille, PhD

• Annex 1 Implementation

Lee Leichter

• Combination Products

Guillaume Lesage

• Filtration

Peter Makowenskyj

• Advanced Manufacturing and Applied Process Digitalization

Toni Manzano

• Advanced Manufacturing and Applied Process Digitalization

Ana Marques Kuschel

• Packaging Science

Gina Marsee

• Pharmacopeial

Thomas Mayer

• Combination Products

Morten Munk

• Management on Outsourced Operations

Malav Parikh

• Quality Risk Management

Anthony Perry

• Packaging Science

Julian Petersen, groninger

• Sterile Processing/Parenteral Drug Manufacturing

William Peterson, Merck

• Filtration

Shelley Preslar

• Facilities and Engineering

Joachim Regel

• Facilities and Engineering

Sabrina Restrepo

• Vaccines

Brigitte Reutter-Haerle

• Pre-Filled Syringe

Doug Roepke

• GMP Links to Pharmacovigilance

John Shabushnig

• Visual Inspection of Parenterals

David Short

• 503B Compounding

Michele Simone

• Quality Systems

Janeen Skutnik-Wilkinson

• Pharmacopeial

Kim Sobien

• Microbiology/Environmental Monitoring

Xu Song

• Packaging Science

Edward H. Trappler

• Lyophilization

Eva Urban

• Quality Systems

Erik van Asselt

• Supply Chain Management

Romain Vellion

• Visual Inspection of Parenterals

Rick Watson

• Visual Inspection of Parenterals