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Tuesday, June 17
 

1:45pm EDT

#252: Harnessing Opportunities Through Inspection Reliance: A Path to Greater Efficiency
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
143ABC
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-590-L04-P; CME 1.00; RN 1.00

During this session, speakers will share insights and recent experiences regarding the implementation of Inspection Reliance from both Regulatory Authorities and Industry perspectives, including unilateral reliance and work-sharing.

Learning Objectives

Identify Recent Trends in Reliance Applications for GMP Inspections and their impact on Supply Chain Sustainability; Describe Risk-Based Approaches for GMP Inspections by National Regulatory Authorities (NRAs); Discuss the modalities and documentation required by Regulatory Authorities for Reliance in GMP Inspections.

Chair

Maria Cristina Mota Pina, MBA

Speaker

Middle East and Africa Perspectives on Inspection Reliance- Panelist
Amira Deia Younes

ANVISA Perspective
Bianca Zimon, LLM

Pathways to Inspection Reliance: A 20 Year Journey
Andrea Kurz, RPh


Speakers
avatar for Andrea Kurz

Andrea Kurz

Senior Director, Lead External Advocacy Europe & Middle East, F. Hoffmann-La Roche Ltd, Switzerland
Andrea Kurz is Senior Director, Lead External Advocacy for Europe and Middle East at Roche in Basel, Switzerland. She has +20 years’ experience in the Pharmaceutical Industry holding various positions in Quality & Compliance and Regulatory Affairs. Andrea is a Pharmacist and graduated... Read More →
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States
Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →
avatar for Bianca Zimon

Bianca Zimon

Health Regulation Specialist, ANVISA, Brazil
Advisor to the International Affairs Office at the Brazilian Health Regulatory Agency (Anvisa). Specialist in Health Regulation and Constitutional Law, with extensive experience in health regulation and enforcement, as well as in bilateral and multilateral negotiations, international... Read More →
avatar for Amira Younes

Amira Younes

Director, Europe, Middle East & Africa (EMEA) Global Regulatory Policy, MSD, United Arab Emirates
Amira is the Global Regulatory Policy Director for Europe, Middle East, and Africa at MSD, with over 14 years of experience in regulatory science and policy. She is recognized as a thought leader in reliance, work sharing, and regional harmonization. Amira has built a strong network... Read More →
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
143ABC Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  10: RegCMC-Product Quality, Session
 
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143ABC
144ABC
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146ABC
146BC
147AB
150AB
151A
151B
152AB
201
202A
204ABC
206
207A
207B
209ABC
Ballroom
Ballroom Foyer 3rd Floor
EH
Exhibit Hall / Zone A
Exhibit Hall / Zone B
Exhibit Hall / Zone C
Exhibit Hall Lunch
Innovation Theater 1
Innovation Theater 2
Innovation Theater 3
L Street Bridge
Nationals Park
Planet Word
Room 145-147 Lobby
Salon B
Salon C
TBD
Virtual
West Salon
  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
  • 06: PersonalizedMed-ComboProd-Diagnostics
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD-Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: ProfDevelopment
  • 13: Spotlight
  • 14: DIAmond
  • 15: Content-Hubs
  • 16: Community-Rounds
  • 17: Posters
  • 18: InnovationTheaters
  • 19: Networking Opportunities
  • 20: Short-Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Keyword
  • Advanced Analytics
  • Artificial Intelligence (AI)
  • Bioethics
  • Biomarkers
  • Cell and Gene Therapy
  • Clinical Trial Design
  • Diagnostics
  • Digital Technology
  • Global Perspectives
  • Non-CE
  • Patient Experience
  • Payers
  • Pediatrics
  • Rare Disease
  • Real-World Data (RWD) / Real-World Evidence (RWE)
  • Regulator Perspectives
  • Regulatory Collaboration
  • Regulatory Convergence and Harmonization
  • Regulatory Reliance
  • Student Programming