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GLOBAL REGULATORY PHARMACEUTICAL SUMMIT Opening Plenary Session
05:00am - 06:10am Eastern - June 16, 2021
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)

Quality Risk Management: Ensuring Shared Responsibility across Key Stakeholders

Sustainable quality risk management depends not only on consistent processes and protocols, but more importantly on the commitment of all key stakeholders. Invited Keynote speakers from EMA, TGA, and FDA-Philippines will share their insights on the positive impact and best practices for collaboration and shared responsibility between regulatory agencies and industry.


Wednesday
Welcome and Opening Remarks
05:00am - 05:02am Eastern - June 16, 2021
Thomas B. Hartman, President and CEO, ISPE; Frances M. Zipp, President & CEO, Lachman Consultant Services

Wednesday
QRM: Experience Since 2005 and Looking to the Future
05:05am - 05:25am Eastern - June 16, 2021
Brendan Cuddy, Lead Scientific Officer, European Medicines Agency (EMA)

Wednesday
Remote GMP Inspections and How to Prepare for Them
05:25am - 05:45am Eastern - June 16, 2021
Benjamin Noyen, Assistant Secretary, Health Products Regulation Group, Therapeutic Goods Administration (TGA)

Wednesday
Quality Risk Management: Ensuring Shared Responsibility across Key Stakeholders
05:45am - 06:05am Eastern - June 16, 2021
Jesusa Joyce Cirunay, RPh, Director IV, Center for Drug Regulation & Research, Food and Drug Administration-Philippines

GLOBAL REGULATORY PHARMACEUTICAL SUMMIT Regulatory and Industry Panel Discussion
06:25am - 08:00am Eastern - June 16, 2021
David Churchward, Moderator, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA; Jesusa Joyce Cirunay, RPh, Panelist, Director IV, Center for Drug Regulation & Research, Food and Drug Administration-Philippines; Brendan Cuddy, Panelist, Lead Scientific Officer, European Medicines Agency (EMA); Cormac Dalton, PhD., Panelist, VP Quality Assurance (EU), AbbVie; Benjamin Noyen, Panelist, Assistant Secretary, Health Products Regulation Group, Therapeutic Goods Administration (TGA); Ranjana B. Pathak, DHA, Panelist, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla Ltd.

A panel of global experts from regulatory agencies and industry will discuss the challenges of maintaining a culture of shared responsibility for quality risk management. Panel members will address questions from the audience on current and critical issues impacting the global supply chain and patient safety.


Wednesday
Regulatory and Industry Panel Discussion
06:25am - 07:55am Eastern - June 16, 2021
David Churchward, Moderator, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA

Wednesday
Closing Remarks
07:55am - 08:00am Eastern - June 16, 2021
Thomas B. Hartman, Session Leader, President and CEO, ISPE

APAC PHARMACEUTICAL MANUFACTURING CONFERENCE Opening Plenary Session
03:00am - 04:30am Eastern - June 17, 2021
Frances M. Zipp, Session Leader, President & CEO, Lachman Consultant Services; Thomas B. Hartman, Speaker, President and CEO, ISPE; Kevin O'Donnell, PhD, Speaker, Market Compliance Mgr & Sr Inspector, Health Products Regulatory Authority (HPRA); Ranjana B. Pathak, DHA, Speaker, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla Ltd.; Carmelo Rosa, PsyD, Speaker, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ
Track: Plenary Sessions
APAC PHARMACEUTICAL MANUFACTURING CONFERENCE Opening Plenary Session | Quality Risk Management: Beyond Theory to Practical Implementation
Many international regulatory authorities have published guidance/draft guidance on Quality Risk Management, as well as ICH and WHO. This fact highlights the importance of QRM in manufacturing and quality operations: it helps coordinate and direct an organization's activities to meet customer and regulatory requirements; it helps in day-to-day decision making within the quality and manufacturing units; it helps ensure the effectiveness of CAPAs; and it helps organizations improve effectiveness and efficiency on a continuous basis. However, despite the clear benefits and need for QRM, organizations often struggle with implementing one fully. In this session, we will discuss the practical implementation of a QRM and how to integrate and avail the organization to the resulting benefits in daily operations and sustainable supply.

Thursday
Welcome and Opening Remarks
03:00am - 03:05am Eastern - June 17, 2021
Thomas B. Hartman, Speaker, President and CEO, ISPE



Thursday
Conference Overview
03:05am - 03:10am Eastern - June 17, 2021
Frances M. Zipp, Session Leader, President & CEO, Lachman Consultant Services

Thursday
Quality Risk Management: Beyond Existing Tools and Models
03:10am - 03:30am Eastern - June 17, 2021
Ranjana B. Pathak, DHA, Speaker, President-Global Quality, Medical Affairs & Pharmacovigilance, Cipla Ltd.

Thursday
Behind the Regulations: Understanding the Intent of Regulatory Guidelines
03:30am - 03:50am Eastern - June 17, 2021
Kevin O'Donnell, PhD, Speaker, Market Compliance Mgr & Sr Inspector, Health Products Regulatory Authority (HPRA)

Thursday
Regulatory Challenges Assessing QRM During the Pandemic
03:50am - 04:10am Eastern - June 17, 2021
Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ

Thursday
Introduction to Case Studies and Session Closing
04:10am - 04:30am Eastern - June 17, 2021
Carmelo Rosa, PsyD, Speaker, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ

CASE STUDIES - ROUND 1 & 2
05:00am - 05:40am Eastern - June 17, 2021



Thursday
CASE STUDY 1: Practical Applications for OOS Investigations/Assessments
05:00am - 05:40am Eastern - June 17, 2021
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
Track: Case Studies
CASE STUDY 1: Practical Applications for OOS Investigations/Assessments | Background to case-studies that will be addressed: Issues observed included observations of repeat testing until a better and/or passing result is obtained; maximum number of retests NOT specified in SOP; vary based on variability of method and is adjusted during OOS Investigation; multiple attempts of retesting and different definition of “retesting”; disregarding OOS results and failure to thoroughly review unexplained discrepancies; product quality failures are ignored without scientific justification. Testing into Compliance: averaging of failed replicates; finding a flaw in the analysis after the run (e.g., Analyst failure/error/ SST/ QA oversight/ Decision making in QC); failure to extend investigation to other batches.
Thursday
CASE STUDY 2: Cross Contamination Controls
05:00am - 05:40am Eastern - June 17, 2021
Antonio C. Crincoli, PE, Moderator, Vice President of Global Engineering, Charles River Laboratories Inc; Vivianne J. Arencibia, Moderator, Independent Consultant, Arencibia Quality Compliance Associates
Track: Case Studies
CASE STUDY 2: Cross Contamination Controls | A lab assay discovers viral residue in a product that was recently released. This plan will include an emergency response describing market action, remediation and plans to effectively communicate with regulatory authorities and customers.
Thursday
CASE STUDY 3: Critical Review of Quality and Manufacturing Data
05:00am - 05:40am Eastern - June 17, 2021
David Churchward, Moderator, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA; Deva H. Puranam, Moderator, Head of Global Quality Investigations, Viatris
Track: Case Studies
CASE STUDY 3: Critical Review of Quality and Manufacturing Data | Emer-Pen is part of General-Pharma’s auto-injector portfolio. It is a single-use drug-device combination product, comprising device components with sterile injectable solution cartridge. Emer-Pen is used in life-threatening emergencies prior to gaining access to qualified medical care. Approximately 4 million packs (2 devices per pack) were prescribed in the local market during financial year 2015-16.
Thursday
CASE STUDY 4: Aseptic Processing Controls
05:00am - 05:40am Eastern - June 17, 2021
Brooke Higgins, Moderator, Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality, FDA/CDER/OC/OMQ; José E. Meléndez, Moderator, Consumer Safety Officer, FDA/ORA
Track: Case Studies
CASE STUDY 4: Aseptic Processing Controls | Imagine the perfect storm. This case study involves a manufacturer of medically necessary sterile drug products and combines numerous failures across various systems. Dive deep into deficiencies associated with media fills, sterility testing, environmental monitoring, aseptic line design, and data integrity and governance.
Thursday
Case Study Report-Outs and Discussion
06:45am - 08:00am Eastern - June 17, 2021
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, Independent Consultant, Arencibia Quality Compliance Associates; 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
Case Study Report-Outs and Discussion |
Adapting During the Pandemic: Changing Regulatory Processes
03:00am - 04:00am Eastern - June 18, 2021
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
Adapting During the Pandemic: Changing Regulatory Processes | The COVID-19 pandemic forced unanticipated change in the way inspections, reviews and EUAs are handled by regulatory agencies and the industry. The impact on supply chain transfers, locations, registrations, and visibility is being felt across the industry.  This session will focus on the regulatory guidance and direction provided by global agencies for adapting to and managing remote processes and unprecedented supply chain needs.
Friday
Session Opening
03:00am - 03:05am Eastern - June 18, 2021
V. Ray Gaines, Session Leader, Branch Chief, Division of Drug Quality I, FDA
The COVID-19 pandemic forced unanticipated change in the way inspections, reviews and EUAs are handled by regulatory agencies and the industry. The impact on supply chain transfers, locations, registrations, and visibility is being felt across the industry. This session will focus on the regulatory guidance and direction provided by global agencies for adapting to and managing remote processes and unprecedented supply chain needs.
Friday
Learning from the Pandemic: Regulatory Adaptation
03:05am - 03:20am Eastern - June 18, 2021
David Churchward, Speaker, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA

Friday
Reviews and Inspections during the Pandemic: What changes will stay, what will go?
03:20am - 03:35am Eastern - June 18, 2021
Carmelo Rosa, PsyD, Speaker, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ

Friday
Q&A/Discussion
03:35am - 03:55am Eastern - June 18, 2021
V. Ray Gaines, Moderator, Branch Chief, Division of Drug Quality I, FDA; David Churchward, Deputy Unit Manager, Inspectorate Strategy and Innovation, MHRA; Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization; Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ

Friday
Session Closing
03:55am - 04:00am Eastern - June 18, 2021
V. Ray Gaines, Session Leader, Branch Chief, Division of Drug Quality I, FDA

Creating Comprehensive Responses To Regulatory Actions
04:15am - 05:15am Eastern - June 18, 2021
Deva H. Puranam, Session Leader, Head of Global Quality Investigations, Viatris; Scott Kaplan, Speaker, Partner, Hogan Lovells; Narendira Kumar, Speaker, Associate Director and Site Quality Head, Dr. Reddy's Lab
Creating Comprehensive Responses To Regulatory Actions | With an increasing number of non-conformances, warning letters/OAIs for sites governed by US regulations, one has to ask what the missing link might be. Companies responding to regulatory actions need to create comprehensive responses that not only address their remediation plan, but also identify how they intend to ensure the sustainability of the remediated processes. Surely, most companies participating this conference must have been through at least one USFDA physical audit. We are all fully aware that our expertise, presentation, knowledge, and behavior are important traits while facing agency investigators during inspection time. What is more important is our post-inspection behavior. How we read and understand a 483, how we respond, and how we communicate with the agency all play a vital role in how we will draw the closure lines. They can be good short ones or a very long one.  Response to a 483 observation is perhaps the last and best opportunity to tell your side of the story before many agency officials (compliance, enforcement, OMQ, OPQ, to name a few) who have not been to your facility and are unaware of what might have happened during the inspection. Form 483 is the living, guiding document for them to assess your facility and make some assumptions of what happened during inspection. You may be surprised to learn that FDA believes it is your responsibility to work with its investigators before they leave your facility to address any inaccuracies on the Form 483.  Fortunately, during these unprecedented times, the FDA has implemented an interim COVID-19 process for communicating with facilities following FDA review of records that will help companies to navigate the post-OAI requirements. Join us as we discuss how to create comprehensive responses to regulatory actions  with industry peers, SMEs, and global regulators (USFDA, MHRA).
Friday
Session Opening
04:15am - 04:20am Eastern - June 18, 2021
Deva H. Puranam, Session Leader, Head of Global Quality Investigations, Viatris
With an increasing number of non-conformances, warning letters/OAIs for sites governed by US regulations, one has to ask what the missing link might be. Companies responding to regulatory actions need to create comprehensive responses that not only address their remediation plan, but also identify how they intend to ensure the sustainability of the remediated processes.
Surely, most companies participating this conference must have been through at least one USFDA physical audit. We are all fully aware that our expertise, presentation, knowledge, and behavior are important traits while facing agency investigators during inspection time. What is more important is our post-inspection behavior. How we read and understand a 483, how we respond, and how we communicate with the agency all play a vital role in how we will draw the closure lines. They can be good short ones or a very long one.
Response to a 483 observation is perhaps the last and best opportunity to tell your side of the story before many agency officials (compliance, enforcement, OMQ, OPQ, to name a few) who have not been to your facility and are unaware of what might have happened during the inspection. Form 483 is the living, guiding document for them to assess your facility and make some assumptions of what happened during inspection. You may be surprised to learn that FDA believes it is your responsibility to work with its investigators before they leave your facility to address any inaccuracies on the Form 483.
Fortunately, during these unprecedented times, the FDA has implemented an interim COVID-19 process for communicating with facilities following FDA review of records that will help companies to navigate the post-OAI requirements. Join us as we discuss how to create comprehensive responses to regulatory actions with industry peers, SMEs, and global regulators (USFDA, MHRA).

Friday
Responding Effectively to Regulatory Inspectional Observations
04:20am - 04:35am Eastern - June 18, 2021
Narendira Kumar, Speaker, Associate Director and Site Quality Head, Dr. Reddy's Lab

Friday
Legal Perspective on Effective Responses to Regulatory Inspections
04:35am - 04:50am Eastern - June 18, 2021
Scott Kaplan, Speaker, Partner, Hogan Lovells

Friday
Q&A/Discussion
04:50am - 05:10am Eastern - June 18, 2021
Deva H. Puranam, Session Leader, Head of Global Quality Investigations, Viatris; Scott Kaplan, Speaker, Partner, Hogan Lovells; Narendira Kumar, Speaker, Associate Director and Site Quality Head, Dr. Reddy's Lab

Friday
Session Closing
05:10am - 05:15am Eastern - June 18, 2021
Deva H. Puranam, Session Leader, Head of Global Quality Investigations, Viatris

CMO/CDMO Relationships, Management, and Quality
05:15am - 06:00am Eastern - June 18, 2021
Aditi S. Thakur, Speaker, Senior Pharmaceutical Quality Assessor, FDA/CDER/OPQ/OPF; Vivianne J. Arencibia, Speaker, Independent Consultant, Arencibia Quality Compliance Associates; Georg Singewald, PhD, VP, Head of Global Quality Control, Genentech, A Member of the Roche Group
CMO/CDMO Relationships, Management, and Quality | As more organizations rely on CMO/CDMOs to meet supply demands, managing multiple sponsor requirements becomes challenging. As a sponsor, ensuring your requirements are met are critical. The track will specifically focus on the process of application and revision of such following significant compliance findings (eg Data Integrity) at the CMO/CDMO. What are some of the expectations if the applicant decides to withdraw the facilities (CMO) specifically under compliance action for the pending applications? What new data would be needed to support the application with the addition of a new site? We will discuss the challenges of a sponsor working with multiple CMOs during a pandemic and provide strategies to ensure adequate controls, oversight and consistency.
Friday
Session Opening
05:15am - 05:20am Eastern - June 18, 2021
Georg Singewald, PhD, Session Leader, VP, Head of Global Quality Control, Genentech, A Member of the Roche Group
As more organizations rely on CMO/CDMOs to meet supply demands, managing multiple sponsor requirements becomes challenging. As a sponsor, ensuring your requirements are met are critical. The track will specifically focus on the process of application and revision of such following significant compliance findings (eg Data Integrity) at the CMO/CDMO. What are some of the expectations if the applicant decides to withdraw the facilities (CMO) specifically under compliance action for the pending applications? What new data would be needed to support the application with the addition of a new site? We will discuss the challenges of a sponsor working with multiple CMOs during a pandemic and provide strategies to ensure adequate controls, oversight and consistency.
Friday
Lessons Learned from Managing Multiple CMOS to Concurrently Produce the Same Product
05:20am - 05:40am Eastern - June 18, 2021
Vivianne J. Arencibia, Speaker, Independent Consultant, Arencibia Quality Compliance Associates

Friday
Understanding the Impact of CMO’s Compliance Action on the Submissions
05:40am - 05:55am Eastern - June 18, 2021
Aditi S. Thakur, Speaker, Senior Pharmaceutical Quality Assessor, FDA/CDER/OPQ/OPF

Friday
Session Closing
05:55am - 06:00am Eastern - June 18, 2021
Georg Singewald, PhD, Session Leader, VP, Head of Global Quality Control, Genentech, A Member of the Roche Group

Regulatory and Industry Panel
06:15am - 07:30am Eastern - June 18, 2021
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
Track: Plenary Sessions
Regulatory and Industry Panel | Maintaining Full Transparency with Regulatory Agencies
Friday
Session Opening
06:15am - 06:20am Eastern - June 18, 2021
Carmelo Rosa, PsyD, Session Leader, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ
Establishing and maintaining full transparency between industry and regulatory agencies is critical to successful daily operations, product quality, and sustainable supply. Clarifying expectations for all parties through consistentand frequent communication and through complete and accurate documentation facilitates the inspection process and when needed, guides responsesto regulatory actions. Routine follow-up holds no surprises and serves to strengthen the regulatory-industry relationship. The process of improving product quality becomes a shared goal for patient safety and access.
Friday
Regulatory and Industry Panel
06:20am - 07:20am Eastern - June 18, 2021
Carmelo Rosa, PsyD, Moderator, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ



Friday
Session Closing
07:20am - 07:30am Eastern - June 18, 2021
Frances M. Zipp, President & CEO, Lachman Consultant Services