Best & Brightest Quality & Regulatory Content from the 2021 Conferences
78 Presentations Featuring 46+ Hours of Content
No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2021, hand-selected the absolute best and brightest Quality & Regulatory presentations and packaged them into the ISPE Best of Pharma Series. Access the most premier presentations offering compelling insights, strategies, and best practices from experts representing global health authorities and leading pharma organizations.
Sneak Peek of What to Expect
Watch this short clip from Tami Frederick presenting Advancing Pharmaceutical Quality: Quality Management Maturity Program for a glimpse of the kind of content you’ll engage within the ISPE Best of Pharma Series: Quality & Regulatory
Presentations in this Package
Containment: Understanding Why, When, and What Regulatory Agencies Expect
Speakers:
- Christa B. Myers, Session Leader, Senior Associate, Aseptic & Sterile Market Director, CRB
- Tom Evans, Director; Environmental Health and Safety, Abzena
- Christoph Knoop, PhD., Principal Research Scientist, AbbVie Deutschland GmbH & Co. KG
- Matthias Angelmaier, Global Product Manager, Isolator Technology, Syntegon Technology GmbH
Duration: 55 min
Plenary Session – Revision of EU GMPs Annex 1: What Impacts Can We Expect as an Industry?
Speakers:
- Jörg Zimmermann, Session Leader, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.
- Jean-Francois Duliere, Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate
- James L. Drinkwater, PE, Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, PHSS, F. Ziel GmbH
Duration: 60 min
Update on Annex 1 Eudralex Vol. 4 Revision
Speakers:
- Jean Francois Duliere, Pharmaceutical Senior Expert, Chair ISPE France Affiliate, Consultant, Chair ISPE France Affiliate
- Jörg Zimmermann, Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.
Duration: 25 min
Annex 1 Revision: High Impact Areas of New Requirements and Points to Consider on Implementation
Speaker:
- James L Drinkwater, P.E., Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, Pharmaceutical & Healthcare Sciences Society
Duration: 10 min
Update PIC/S Annex 2A Draft for ATMPs Revision
Speakers:
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
- Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences
Duration: 30 min
Regulatory and Industry Panel
Speakers:
- David Doleski, Compliance Head for Biologics Quality Operations, Sanofi
- Robert Sausville, Director, Div. Case Management, FDA/CBER/OMPT/OCBQ
- Abdelaali Sarakha, PhD, Senior GMP Inspector, Annex 1 Rapporteur, French Health Products Safety Agency (ANSM)
- Alan Moon, Senior GMDP Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA)
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
- Brooke Higgins, Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality, FDA/CDER/OC/OMQ
- Richard Friedman, CDER/FDA
- Thomas J. Arista, Consumer Safety Officer, FDA/ORA
- Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA
Duration:106 min
US Food and Drug Administration (US FDA)
Speaker:
- Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA
Duration: 15 min
European Medicines Agency (EMA)
Speaker:
- Brendan Cuddy, Lead Scientific Officer, Clinical Studies and Manufacturing Taskforce, EMA
Duration: 15 min
Medicines and Healthcare Regulatory Agency (MHRA)
Speaker:
- David Churchward, Deputy Unit Manager, Inspectorate Strategy & Innovation, MHRA
Duration: 15 min
Health Products Regulatory Authority (HPRA) & Pharmaceutical Inspection Co-Operation Scheme (PIC/S)
Speaker:
- Anne Hayes, Inspection Manager, Compliance & PIC/S Chair
Duration: 15 min
Regulatory Panel Discussion
Speakers:
- Brendan Cuddy, Lead Scientific Officer, Clinical Studies and Manufacturing Taskforce
- David Churchward, Deputy Unit Manager, Inspectorate Strategy & Innovation, MHRA
- Joey Gouws, PhD Team Lead, Inspection Services, Prequalification Team
- Carmelo Rosa, PsyD, Director, Division of Drug Quality
- Alonsa Cruse, Director, Office of Pharmaceutical Quality Operations
- Vladislav Shestakov, Director, Deputy Head of Russian State GMP Inspectorate
- Jacques Morenas, Technical Advisor of the Inspection Division Director, ANSM
- Marisa Delbò, Head of Risk Management Office AIFA
- Manuel Ibarra, Lorente, Head of Department, Pharmaceutical Inspection & Enforcement Department
- Klaus Eichmüller, Regierungspräsidium Darmstadt in Darmstadt, Hessen Anne Hayes, Inspection Manager, Compliance & PIC/S Chair
Duration: 120 min
QRM: Experience Since 2005 and Looking to the Future
Speaker:
- Brendan Cuddy, Lead Scientific Officer, European Medicines Agency (EMA)
Duration: 20 min
Remote GMP Inspections and How to Prepare for Them
Speaker:
- Benjamin Noyen, Assistant Secretary, Health Products Regulation Group, Therapeutic Goods Administration
Duration: 20 min
Quality Risk Management: Ensuring Shared Responsibility across Key Stakeholders
Speaker:
- Jesusa Joyce Cirunay, RPh, Director IV, Center for Drug Regulation and Research, FDA Philippines
Duration: 20 min
Regulatory and Industry Panel Discussion
Speakers:
- David Churchward, Deputy Unit Manager, Inspectorate Strategy & Innovation, MHRA
- Jesusa Joyce Cirunay, RPh, Director IV, Center for Drug Regulation and Research, FDA Philippines
- Brendan Cuddy, Lead Scientific Officer, European Medicines Agency (EMA)
- Cormac Dalton, VP Quality Assurance (EU) AbbVie
- Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER
- Benjamin Noyen, Assistant Secretary, Health Products Regulation Group, Therapeutic Goods Administration
- Ranjana Pathak, DHA, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla Ltd.
Duration: 95 min
Opening Plenary Session – Quality Risk Management: Beyond Theory to Practical Implementation
Speakers:
- Thomas B. Hartman, Session Leader, President and CEO, ISPE
- Frances M. Zipp, Speaker, President & CEO, Lachman Consultant Services
- Brendan Cuddy, Speaker, Lead Scientific Officer, European Medicines Agency (EMA)
- Jesusa Joyce Cirunay, RPh, Speaker, Director IV, Center for Drug Regulation & Research, Food and Drug Administration-Philippines
- Benjamin Noyen, Speaker, Assistant Secretary, Health Products Regulation Group, Therapeutic Goods Administration (TGA)
Duration: 70 min
Quality Risk Management: Beyond Existing Tools and Models
Speaker:
- Ranjana Pathak, DHA, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla Ltd.
Duration: 20 min
Behind the Regulations: Understanding the Intent of Regulatory Guidelines
Speaker:
- Kevin O’Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority, Ireland (HPRA)
Duration: 20 min
Regulatory Challenges Assessing QRM During the Pandemic
Speaker:
- Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER
Duration: 20 min
Case Study 1: Practical Applications for Out-of-Specification Investigations/Assessments
Speakers:
- Georg Singewald, PhD, Moderator, VP, Head of Global Quality Control, Genentech, A Member of the Roche Group;
- Aditi S. Thakur, Moderator, Senior Pharmaceutical Quality Assessor, FDA/CDER/OPQ/OPF
Duration: 40 min
Case Study 2: Cross Contamination Controls
Speakers:
- Vivianne Arencibia, Principal, Arencibia Quality Compliance Associates
- Tony (Antonio) Crincoli, PE, Vice President of Global Engineering, Charles River Laboratories Inc.
Duration: 75 min
Case Study 3: Critical Review of Quality and Manufacturing Data
Speakers:
- Deva Puranam, Head of Global Quality Investigations, Viatris
- David Churchward, Deputy Unit Manager, Inspectorate Strategy, and Innovation, MHRA
Duration: 40 min
Case Study 4: Aseptic Processing Controls
Speaker:
-
José Meléndez, Consumer Safety Officer, FDA/ORA Brooke Higgins, Senior Policy Advisor, Office of Manufacturing Quality, CDER/FDA
Duration: 75 min
Case Study Report-Outs and Discussion
Speakers:
- Georg Singewald, PhD, VP, Head of Global Quality Control, Genentech, A Member of the Roche Group
- Frances M. Zipp, Session Leader, President & CEO, Lachman Consultant Services;
- Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ;
- Aditi S. Thakur, Senior Pharmaceutical Quality Assessor, FDA/CDER/OPQ/OPF;
- Vivianne J. Arencibia, Vice President, Global Quality Systems & Compliance, Moderna;
- Antonio C. Crincoli, PE, Vice President of Global Engineering, Charles River Laboratories Inc;
- David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA;
- Deva H. Puranam, Head of Global Quality Investigations, Viatris;
- Brooke Higgins, Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality, FDA/CDER/OC/OMQ;
- José E. Meléndez, Consumer Safety Officer, FDA/ORA
Duration: 75 min
Adapting during the Pandemic: Changing Regulatory Processes
Speakers:
- V. Ray Gaines, Session Leader, Branch Chief, Division of Drug Quality I, FDA
- David Churchward, Speaker, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA
- Carmelo Rosa, PsyD, Speaker, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ
- Joey Gouws, PhD, Panelist, Team Lead, Inspection Services, Prequalification Team, World Health Organization
Duration: 60 min
Learning from the Pandemic: Regulatory Adaptation
Speaker:
- David Churchward, Deputy Unit Manager, Inspectorate Strategy, and Innovation, MHRA
Duration: 15 min
Creating Comprehensive Responses to Regulatory Actions
Speaker:
- Deva Puranam, Head of Global Quality Investigations, Viatris
Duration: 10 min
Responding Effectively to Regulatory Inspectional Observations
Speaker:
- Narendira Kumar, Associate Director and Site Quality Head, Dr. Reddy’s Lab
Duration: 30 min
Legal Perspective on Effective Responses to Regulatory Inspections
Speaker:
- Scott Kaplan, Partner, Hogan Lovells
Duration: 20 min
CMO/CDMO Relationships, Management, and Quality
Speaker:
- Georg Singewald, PhD, VP, Head of Global Quality Control, Genentech
Duration: 45 min
Lessons Learned from Managing Multiple CMOs to Concurrently Produce the Same Product
Speaker:
- Vivianne Arencibia, Principal, Arencibia Quality Compliance Associates
Duration: 15 min
Understanding the Impact of CMO’s Compliance Action on the Submissions
Speaker:
- Aditi Thakur, Senior Pharmaceutical Quality Assessor, FDA/CDER
Duration: 20 min
Regulatory and Industry Panel: Maintaining Full Transparency with Regulatory Agencies
Speakers:
- Carmelo Rosa, PsyD, Session Leader, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ;
- Jila Breeze, Panelist, EVP, Global Head Quality & Compliance, SUN Pharmaceutical Industries, Inc.;
- Davide Buratti, GxP Compliance Operations Director - Partner, PQE Group;
- David Churchward, Panelist, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA;
- V. Ray Gaines, Panelist, Branch Chief, Division of Drug Quality I, FDA;
- R. Derek Glover, Panelist, Head of Global Quality, Viatris;
- Joey Gouws, PhD, Panelist, Team Lead, Inspection Services, Prequalification Team, World Health Organization;
- Brooke Higgins, Panelist, Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality, FDA/CDER/OC/OMQ;
- José E. Meléndez, Panelist, Consumer Safety Officer, FDA/ORA;
- Kevin O'Donnell, PhD, Panelist, Market Compliance Mgr & Sr Inspector, Health Products Regulatory Authority (HPRA);
- Ranjana B. Pathak, DHA, Panelist, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla Ltd.;
- Aditi S. Thakur, Panelist, Senior Pharmaceutical Quality Assessor, FDA/CDER/OPQ/OPF;
- Frances M. Zipp, Panelist, President & CEO, Lachman Consultant Services
Duration: 70 min
Cellular and Gene Therapy Products: A CMC Regulatory Perspective
Speaker:
- Carolyn Laurencot, Associate Director for Regulatory Science and Review, Division of Cellular & G, FDA (US Food and Drug Administration)
Duration: 30 min
Individualised Neo-Antigen-Specific Therapies: Unique CMC Challenges and a Novel Regulatory Framework
Speaker:
- Amy Hardwick, Technical Regulatory Program Associate Director, INeST, Genentech
Duration: 20 min
Panel Discussion with Speakers in "Track 4: Cell and Gene Therapy, ATMPs, Data Science Research and Development" and Closing Remarks
Speakers:
- Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences;
- Volker Huppert, Chief Development Officer, Glycostem Therapeutics
- René Thürmer, Quality Assessor, BfArm
- Daniel P. DeCollibus, Sr. Scientist, Process Development, Amgen
- Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
- Giuseppina Sandri, Associate Professor, University of Pavia
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
Duration: 25 min
Panel Discussion with Regulators and Closing Remarks
Speakers:
- Wilson W. Bryan, M.D., Director, Office of Tissues and Advanced Therapies, CBER/FDA
- Matthew JH Davis, Senior GMP Inspector, Therapeutic Goods Administration
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
- René Thürmer, Quality Assessor, BfArm
- Thomas B. Hartman, President and CEO, ISPE
Duration: 40 min
Regulatory Resiliency in Challenging Times
Speaker:
- Elizabeth Miller, Pharm. D., Assistant Commissioner for Medical Products and Tobacco Operations, ORA/FDA
Duration: 25 min
From Defect Detection to Contaminant Characterization
Speaker:
- Andrea Sardella, PhD, Pharma Inspection Product Development, Stevanato Group S.P.A.
Duration: 20 min
Achieving GxP Agility with Islands of Automation
Speakers:
- John C. Spohn, CPIP, Principal Project Engineer, Castle Hill Technologies, Inc.
- John Robert Parraga, Director, Process Automation, ECSSolutions
Duration: 15 min
Concurrent Session: Digital Innovation: Ensuring Quality and Regulatory Compliant Solutions
Speakers:
- Eric Staib, Vice President of Compliance & Quality Management, Signant Health
- Alice Rystov, Senior Automation Engineer, JSat Automation
Duration: 90 min
Computer Software Assurance & Automation (Paperless)
Speaker:
- Meher Muttanapalli, Senior Quality Validation Manager, Johnson & Johnson
Duration: 20 min
Applying a GAMP® 5 Framework to AI/ML
Speaker:
- Eric J. Staib, MS, MBA, Vice President of Compliance & Quality Management, Signant Health
Duration: 20 min
Documenting the Machine Learning Life Cycle
Speaker:
- Brandi Stockton, Senior Director, Quality & Compliance, Medocity, Inc.
Duration: 30 min
To Catch a Template - Best Practices Supporting QRM the C&Q process
Speaker:
- Midhu Varghese, Associate Director, Commissioning & Qualification, AbbVie, Inc.
Duration: 20 min
Lean Integrated CQV - Case Studies and Lesson Learned from CGT
Speaker:
- David Macdonald, Principal Engineer, Hyde Engineering and Consulting
Duration: 20 min
Concurrent Session: Drug Shortages and Meeting Supply Chain Challenges
Speakers:
- Christian Wölbeling, Leader/Speaker, Executive Industry Advisor, Körber;
- Drishya Nair, Manager, Life Sciences Consulting, Ernst & Young US LLP;
- Stephanie G. Garth, Vice President, Quality Assurance North America, The Binding Site;
- Jay Welsh, Partner & Supply Chain Leader, Ernst & Young US LLP
Duration: 80 min
ISPE Pharma 4.0™ - Managing the Development Supply Chain
Speaker:
- Christian Wölbeling, Executive Industry Advisor, Körber
Duration: 25 min
ISPE Drug and Device Shortages: Business Continuity Planning
Speakers:
- Jay Welsh, Partner & Supply Chain Leader, Ernst & Young US LLP
- Stephanie G. Garth, Vice President, Quality Assurance North America, The Binding Site
- Drishya Nair, Manager, Life Sciences Consulting, Ernst & Young US LLP
Duration: 35 min
Concurrent Session: Path to a Global Quality Dossier - Part 1
Speakers:
- Gregory Rullo, Session Leader, Senior Director, Regulatory Affairs-CMC, AstraZeneca Pharmaceuticals;
- Timothy J.N. Watson, PhD, Executive Director & Team Leader, CMC Advisory Office, Pfizer Inc;
- Ciby Abraham, PhD, Director, Regulatory CMC, AstraZeneca;
- Rodrigo Palacios, Associate Director, Global Regulatory Policy, F. Hoffmann-La Roche AG
Duration: 80 min
Control Strategy Harmonization Metrics and Importance of ICHQ12
Speaker:
- Timothy J.N. Watson, PhD, Executive Director & Team Leader, CMC Advisory Office, Pfizer Inc
Duration: 25 min
Risk Based Quality Overall Summary
Speaker:
- Ciby Abraham, PhD, Director, Regulatory CMC, AstraZeneca
Duration: 30 min
Cloud-Based Submissions and Structured Data | Accumulus Summary
Speaker:
- Rodrigo Palacios, Associate Director, Global Regulatory Policy, F. Hoffmann-La Roche AG
Duration: 25 min
The Ultimate Friend Request: Global CDMO Tech Transfer
Speakers:
- Amanda Culliton, Senior Project Manager, Cytiva
- Mohamed Shaker, Scientist, Cytiva
Duration: 20 min
Cleaning Considerations: Design, Start-up, and Commissioning
Speaker:
- Paul T. Lopolito, Technical Services Senior Manager, Steris Corporation
Duration: 15 min
Digital Tech Transfer / Scale-up
Speakers:
- Daniel A. UpDyke, P.E., Life Sciences Market Development Manager, Rockwell Automation
- Sachin Misra, Pharmaceuticals & Biotech Industry Principal, Kalypso
Duration: 30 min
Patient Centricity in the Post Approval Space|Balancing the Data with the Story
Speakers:
- Sarah C. Pope Miksinski, PhD, Senior Director in Regulatory CMC, AstraZeneca
- Angela Currie, PhD, CMC Reg Affairs Senior Director and Group Manager, AstraZeneca
Duration: 20 min
ICH M4Q Revision: An Opportunity for a Global Quality Dossier
Speaker:
- Lawrence X. Yu, PhD, Director, Office of New Drug Products, OPQ/CDER/FDA
Duration: 30 min
Modern vs Classical DOE - Reduce Runs and Expand Modelling
Speaker:
- Tara Scherder, Principal, SynoloStats
Duration: 35 min
AI Maturity Model for GxP Application
Speakers:
- Rolf Blumenthal, Business Developer, Körber Pharma Software
- Nico Erdmann, PhD, Manager | Risk Adivsory, Deloitte GmbH
Duration: 30 min
Concurrent Session: Lifecycle Management and Modernization
Speakers:
- Dante Amatangelo, Session Leader, Project Manager, Ellab Inc.;
- Mario Moreira, Principal Consultant, Emergn;
- Elizabeth A. McLellan, VP, Compliance & Quality and Data Protection Officer, Suvoda;
- Ken Shitamoto, Senior Director, IT, Gilead Sciences;
- Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations, Compliance Group;
- Rolf Blumenthal, Business Developer, Körber Pharma Software
Duration: 75 min
Discovery Mindset: Benefit Patients Through Fast Time to Market
Speakers:
- Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations, Compliance Group
- Ken Shitamoto, Senior Director, IT, Gilead Sciences
Duration: 10 min
Modernization – Lessons Learned Collaborating with GAMP® and CSA
Speakers:
- Khaled Moussally, Executive Vice President Quality - Clients & Regulatory Relations, Compliance Group
- Ken Shitamoto, Senior Director, IT, Gilead Sciences
Duration: 30 min
Resilient Manufacturing for Handling Disruptions
Speakers:
- Brian Curran, Senior Vice President of Manufacturing Customer Success, MasterControl
- Regina Maria Fullin, Vice President of Regulatory Affairs and Quality Assurance Consulting, Compliance Team, LLC
Duration: 30 min
Concurrent Session: Advancing Pharmaceutical Quality - Quality Management Maturity
Speakers:
- Tami Frederick, Senior Director, Corporate Quality Systems and Cultural Excellence, Perrigo
- Haley Durbin, Manufacturing Systems & Compliance Specialist, Sequence Inc.
Duration: 130 min
Advancing Pharmaceutical Quality: Quality Management Maturity Program
Speaker:
- Tami J. Frederick, Senior Director, Corporate Quality Systems & Cultural Excellence, Perrigo
Duration: 10 min
Advancing Pharmaceutical Quality: Management Responsibilities and Management Review Practical Guide
Speaker:
- Michael Grischeau, Director of Data Analytics & Management Review, AbbVie Inc
Duration: 15 min
An Update on CDER’s Pilot Programs: Quality Metrics (QM) and Quality Management Maturity (QMM)
Speaker:
- Nandini Rakala, PhD, Visiting Associate, U.S. FDA
Duration: 25 min
Supply Chain Business Continuity in Drug Development
Speaker:
- Bikash K. Chatterjee, Chief Executive Officer, Pharmatech Associates, Inc.
Duration: 30 min
Alternative GMP/GDP Inspection Practices
Speaker:
- Sarah Barkow, PhD, Director GxP External Engagement, BMS
Duration: 10 min
Pandemic Lessons Learned: The Regulatory Inspections Toolbox
Speaker:
- Stephan Rönninger, Dr.-Ing., Director, Quality External Affairs, Amgen (Europe) GmbH
Duration: 10 min
Lessons Learned on Virtual Inspections and What to Take Forward Post-Pandemic
Speakers:
- Jennifer Maguire, PhD, Deputy Director, Office of Quality Surveillance, CDER/FDA
- Ewan Norton, Lead Senior GMDP Inspector, MHRA
- Ian Jackson, Unit Manager, Inspection Risk, Control and Governance, MHRA
- Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization
Duration: 65 min
Risk Mitigation for Higher Levels of Data Integrity
Speaker:
- Rick Jarrell, Business Development – Life Science – Americas, Eurotherm by Schneider Electric
Duration: 20 min
Supplier Qualification for Non-GMP Regulated Materials
Speaker:
- Elizabeth Rivera, Technical Services Manager, STERIS Corp
Duration: 15 min
Digital Compliance: Practical Considerations to Modernize CSV and Adopt CSA
Speaker:
- Dori Gonzalez-Acevedo, MA, Vice President of Strategic Solutions, Tx3 Services
Duration: 20 min
Concepts and Perspectives on Analytical Procedures: (ICH Q2(R2)/Q14)
Speaker:
- Nina S. Cauchon, PhD, Director Regulatory Affairs - CMC, Amgen Inc.
Duration: 20 min
ICH Q9 (R1) Quality Risk Management Revision – Why Now?
Speaker:
- Stephen Mahoney, Executive Director, Global Quality & Compliance, Genentech, A Member of the Roche Group
Duration: 10 min
Progress on the Global Adoption and Implementation of ICH Q12
Speaker:
- Andrew Chang, PhD, Vice President, Quality and Regulatory Compliance, Novo Nordisk Inc.
Duration: 20 min
Global Regulatory Town Hall: Global Regulatory Insights on Current Issues – Harmonization and Convergence
Speakers:
- Betsy Fritschel, Director, Enterprise Regulatory Compliance, Johnson & Johnson
- Sarah Pope Miksinksi, Senior Director, AstraZeneca Ian Jackson, Unit Manager, Inspection Risk, Control and Governance, MHRA
- Ewan Norton, Lead Senior GMDP Inspector, MHRA
- Ian Rees, Unit Manager Inspectorate Strategy & Innovation, MHRA
- Joey Gouws, Team Lead, Inspection Services, Prequalification Team, WHO
- Jennifer Maguire, Director, Office os Quality Surveillance, OPQ/CDER/FDA
- Lawrence Yu, Director, Office of New Drug Products, FDA
- Roberto Conocchia, Senior GMP Inspector, European Medicines Agency (EMA)
- Mahesh Ramanadham, PharmD, MBA, Associate Director for Scientific Operations, FDA/OPMA/OPQ
- Raphael Sanches Pereira, Small Molecules Quality Assessment Manager (GQMED) ANVISA
- Tara Gooen Bizjak, Senior Science Policy Advisor, OPQ/CDER/FDA