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- Opening Ceremony
- E-Submissions: Opportunities and Challenges • Introduction by the Moderator
Micheal Schafferius
Micheal Schafferius
Application Specialist at Sartorius Australia
- Using AI/ML for Optimising Regulatory Operations
Niels LeanderBased on concrete examples from the regulatory operations area, this presentation will give insight into the current state of the use of AI/ML in the functions managing regulatory documents and data. From data quality monitoring to improvement of regulatory information management systems, the presentation will show how easy it is to get started reaping the benefits of AI, as the technology has matured.
Niels Leander
Associate Vice President, Regulatory Affairs at NNIT
- The Evolution of Regulatory Review towards Data Collaborative Review with Accumulus
David RossThe opportunities and evidence for data exchange at a global level are surveyed. We are working to define data terminology (structured, unstructured, metadata), highlighting grey areas between narratives, visualization and how to structure narrative / generate content for reusability and automation whilst adhering to various data standards (i.e. ICH, ISO, etc.) . Alongside, we are surveying Health Authority’s approaches to data such as FDA PQ/CMC to FHIR, EMAs EU CTR and Big Data. While the focus is on harmonization, global Health Authorities’ challenges to data harmonization within an enterprise (e.g. LIMS, RIM, Clinical, Quality systems) is also highlighted. Reference is made to an industry wide Enterprise Data Model, that AZ is socializing. Finally, Accumulus vision for Data Exchange operability is discussed as one solution for global data collaboration and aid in streamlining the review process between Health Authorities and Sponsors. We will outline the potential benefits that Accumulus vision provides for data exchange and modernization by dealing directly with data exchange instead of content/document exchange.
David Ross
Program Lead, Accumulus Synergy AZ, Regulatory Affairs at AstraZeneca
- Panel Discussion and Q&A
David Ross•Micheal Schafferius•Brooke CasselberryMicheal Schafferius, David Ross and Brooke Casselberry
David Ross
Program Lead, Accumulus Synergy AZ, Regulatory Affairs at AstraZenecaMicheal Schafferius
Application Specialist at Sartorius Australia
Brooke Casselberry
Associate Vice President at NNIT
- Product Demo by Merck Life Science, Explore What’s Next in Process Solutions
Nantanut Prateepsritorn
Head of Marketing Communications South Asia & Oceania
Merck KGaA - Lunch Break
- New and Revised cGMP Regulatory Codes and Guidelines • Introduction by the Moderator
- PIC/S EMA Working Group Annex 1 Update
Matt Davis
Matt Davis
Senior Inspector at Therapeutic Goods Administration - Australian Government
- New EMA / PIC/S Annex 1 – Selected Highlights
Bruce LoxleyThe new Annex 1 is issued, we can all access it easily on the internet and read it, so why is it necessary for someone to explain it to you?!
In this presentation, Bruce Loxley from GSK Vaccines and PDA Science Advisory Board member will dissect some of the main themes but also the more nuanced changes, that are more minor yet important. The 2 main headlines are the requirement to develop a Contamination Control Strategy, and the requirement to implement PUPSIT, and indeed these topics will be talked about. However, significant emphases are also being put on lesser-known topics such as particle counter tubing, gown integrity and even process drain maintenance! These deserve highlighting and awareness so that your facility’s parenteral drug manufacturing will continue to meet regulatory expectations come the deadline for implementation.
Bruce Loxley
Senior GMP Compliance Advisor at GlaxoSmithKline Vaccines
- Sample
synopsis / abstract
- Panel Discussion and Q&A
Lisa Bennett•Bruce Loxley•Matt Davis
Lisa Bennett
Senior GMP Compliance Consultant & Trainer at SeerPharmaBruce Loxley
Senior GMP Compliance Advisor at GlaxoSmithKline VaccinesMatt Davis
Senior Inspector at Therapeutic Goods Administration - Australian Government
- Audit Review • Introduction by the Moderator
Lisa BennettLisa Bennett
Senior GMP Compliance Consultant & Trainer at SeerPharma
- The Good News about FDA's Quality Management Metrics (QMM) and Our Data Governance Journey
Peter Baker
Peter Baker
President at Live Oak Quality Assurance LLC
- Data Governance and Quality Culture
Di Morris
Di Morris
Senior Auditor, Development and Product Quality Group at AstraZeneca
- Data Integrity
Robert CaunceNot another presentation on data integrity and the ALCOA + principles. The presentation will allow both sides of the picture to be provided, what the TGA and FDA wants and how can industry manage the expectations and off course where to find some light reading on data integrity with some examples.
Robert Caunce
Technical Manager at Baxter Laboratories Pty Ltd
- FDA Quality Management Maturity White Paper
Steven MendivilSteven's talk will provide an overview of FDA's QMM program, the pilot and how PDA's Quality Culture Maturity Model may have played a key role in its development and where it might be going.
It will also touch on what we know about the pilot and what we don't know yet about the QMM program that is still being developed.
Steven Mendivil
External Affairs at Amgen
- Panel Discussion and Q&A
Lisa Bennett•Robert Caunce•Steven Mendivil•Di MorrisLisa Bennett
Senior GMP Compliance Consultant & Trainer at SeerPharmaRobert Caunce
Technical Manager at Baxter Laboratories Pty LtdSteven Mendivil
External Affairs at AmgenDi Morris
Senior Auditor, Development and Product Quality Group at AstraZeneca
- Product Demo by OpTek Systems: Contains Closure Integrity Testing, and Integrated View of Positive Controls
Chris Randon – Manager, OpTek Systems
Henry Lu – Unit Manager, OpTek Systems - Lunch Break
- Lessons Learned During the Pandemic • Introduction by the Moderator
Dinesh Khokal
Dinesh Khokal
Director, External Affairs, JAPAC and Intercontinental - LatAm of Amgen
- Lessons Learned During the Pandemic: Philippine FDA Experience
Jesusa Joyce CirunayChallenges and Regulatory Actions. FDA Philippines is tasked to ensure public safety through assuring the quality, safety and efficacy of health products. Particularly, in the time of the pandemic FDA continues to ensure efficient public service despite the difficulties in normal operations, and still strive for improvement i.e. streamlining the requirements and applications to our Offices. The challenges encountered by FDA Philippines is discussed and the regulatory actions, i.e. adoption of reliance policies, interim guidelines, and facilitated pathways, undertaken to address these challenges. Lessons Learned and Ways Forward. Also discussed are the lessons learned by FDA in the regulation of health products in the face of pandemic. Adoption of improved and established policies has to be conducted to be ready for public health emergencies.
Jesusa Joyce Cirunay
Director IV of the Center for Drug Regulation and Research at Food and Drug Administration, Philippines
- Overview of Cross-company CMC Discussions Related to COVID-19 Vaccines
Cristiana CampaThe presentation will report an update on learnings from COVID-19 health emergency, focusing on chemistry, manufacturing and controls (CMC) elements. The content will be based on the recent discussions within the Vaccines Europe/ IFPMA CMC COVID task force, which is progressively shifting focus from addressing the emergency to pandemic preparedness.
Cristiana Campa
Global Advisor and Fellow, Technical R&D at GSK
- Post-approval Changes • Introduction by the Moderator
Bruce LoxleyBruce Loxley
Senior GMP Compliance Advisor at GlaxoSmithKline Vaccines
- A Case Study Comparing and Contrasting China NMPA and US FDA Requirements for Major Post-Approval Changes (Such as Manufacturing Site Change and Scale-up)
Max FernandezGlobal expansion of a biological product’s manufacturing network to meet commercial needs is achieved through well-defined regulatory pathways in ICH markets. Although considered a major post-approval change, manufacturing site additions, scale-up, and related process changes are now submitted, reviewed, and approved routinely by major health authorities such as the US FDA and EMA. In contrast, marketing authorization holders may consider the regulatory pathways in countries such as China to be a “black box” where requirements for successfully implementing a major post-approval change are not obvious or transparent. In this presentation, Max Fernandez demystifies the requirements in China for successful approval of a manufacturing site addition and scale-up by presenting a case study from a CDMO perspective, and discusses strategies to efficiently implement this major CMC change.
Max Fernandez
Vice President at Intellective Bio
- ICH Q12 and Challenges with PACs
Gopi VudathalaThe recent guideline issued by the International Conference on Harmonization (ICH) has been instrumental to pharmaceutical industry improvements in quality systems and in understanding the key aspects of manufacturing processes. Implementing the ICH quality guidelines (Q8–Q11) allows companies entering the product lifecycle to achieve product realization, and to establish and maintain the state of control required in routine manufacturing. However, given the global nature of the pharmaceutical industry, management of post-approval changes (PAC) and continual manufacturing improvements is inconsistent, based on the regulatory needs of worldwide regulatory agencies.
Firms and manufacturers involved in pharmaceutical manufacturing need to build upon the ICH foundational elements in order to advance how changes are regulated within effective Pharmaceutical Quality Systems (PQS).
The key challenges encountered in making post-approval changes will be discussed in the presentation as well as how PACs can be optimized.
Gopi Vudathala
Global Head, GRA CMC at Incyte Corp
- Three ways to make manufacturing changes without regulatory approval
Janmeet AnantThe biopharmaceutical manufacturing industry is going through a paradigm shift; however, it seems sometimes that no one is moving. The industry overall is highly risk averse and conservative. Many of the biologic drug manufacturers blame regulatory agencies for stifling innovation, while regulatory representatives state that they encourage innovation and cite various progressive cGMP guidance documents to support this fact. The shift encouraged by regulators is a move from rule-based compliance to a quality risk management (QRM) approach.
The recently finalized ICH Q12 guidance, aligned with WHO Annex 3 and 4 for biotherapeutics and vaccines, respectively, have encouraged the utilization of QRM. In this presentation, I will highlight three ways to make changes to biopharmaceutical manufacturing without requiring regulatory approval. Multiple case studies will be highlighted to empower biotherapeutic and vaccine manufacturers to innovate and make changes more efficiently by reducing the burden of regulatory oversight.
Janmeet Anant
Senior Regulatory Consultant at Millipore Sigma
- Panel Discussion and Q&A
Janmeet Anant•Cristiana Campa•Jesusa Joyce Cirunay•Max Fernandez•Bruce Loxley•Gopi Vudathala•Dinesh KhokalJanmeet Anant
Senior Regulatory Consultant at Millipore SigmaCristiana Campa
Global Advisor and Fellow, Technical R&D at GSKJesusa Joyce Cirunay
Director IV of the Center for Drug Regulation and Research at Food and Drug Administration, PhilippinesMax Fernandez
Vice President at Intellective BioBruce Loxley
Senior GMP Compliance Advisor at GlaxoSmithKline VaccinesGopi Vudathala
Global Head, GRA CMC at Incyte CorpDinesh Khokal
Director, External Affairs, JAPAC and Intercontinental - LatAm of Amgen
- New Technology Applications and Their Impact to Regulatory Oversight • Introduction by the Moderator
Lisa BennettLisa Bennett
Senior GMP Compliance Consultant & Trainer at SeerPharma
- AI/ML in Medicine Regulation – Regulator and Industry Perspectives
Phil TregunnoThe presentation will provide an overview of the UK's Medicines and Healthcare products Regulatory Agency's perspective on the use of Artificial Intelligence and Machine Learning, reflecting on the Agency's experience from use of the technology during the COVID-19 pandemic. The presentation will explore challenges identified and strategies to address those issues.
Phil Tregunno
Head of Vigilance Operations, Safety and Surveillance at Mhra
- Regulatory Challenges and Opportunities for Agile Manufacturing
Dr Celeste Frankenfeld LammNew technology, such as Portable On-Demand (POD) manufacturing, requires regulatory flexibility; as technology adapts to enable modular, portable, distributed, and point of care manufacture to meet patient needs, so should the regulatory framework. This talk will discuss scenarios where flexible manufacturing may be needed, as well as current regulatory challenges that can slow implementation. Finally, examples of regulatory updates in Great Britain and the United States that are progressing POD manufacturing will be provided.
Dr Celeste Frankenfeld Lamm
Director, Global Regulatory Affairs - CMC of MSD
- Panel Discussion and Q&A
Dr Celeste Frankenfeld Lamm•Dr Dominic Nguyen-Van-Tam•Phil Tregunno•Lisa BennettDr Celeste Frankenfeld Lamm
Director, Global Regulatory Affairs - CMC of MSD
Dr Dominic Nguyen-Van-Tam
Compliance Senior Manager at AmgenPhil Tregunno
Head of Vigilance Operations, Safety and Surveillance at MhraLisa Bennett
Senior GMP Compliance Consultant & Trainer at SeerPharma
- Break
- Supply Chain Integrity and Drug Shortages • Introduction by the Moderator
Lisa BennettLisa Bennett
Senior GMP Compliance Consultant & Trainer at SeerPharma
- Attribute Based Approach to Risk Management and Alternate Sources for Raw Materials
Jackie Milne
Jackie Milne
Director, Process Development (Attribute Sciences) of Amgen
- Mitigating Risk to Container Closure Integrity of a mRNA Vaccine During Ultra-Cold Chain Storage and Distribution
Derek Duncan•Michael EdeyChanges in regulatory guidance on container closure integrity (CCI), including text in the revised EU Annex 1, have triggered an evolution in best practices to ensure that sterile product has good CCI. This includes validating a deterministic CCI test method to generate CCI data on the primary packaging components. The management of processes and manufacturing activities in accordance with Quality Risk Management (QRM) provides a proactive means of identifying, scientifically evaluating, and mitigating potential risks to quality as well as defining contamination control strategies. A QRM approach was used with QbD principles applied to develop CCIT requirements. Analytical CCI data was generated using test methods based on laser-based headspace analysis. The science-based holistic approach described can be considered a best practice approach for upcoming therapies needing ultra-cold chain for storage and distribution and can be generalized to other container and product configurations.
Derek Duncan
Director of Product Line at LIGHTHOUSE
Michael Edey
Senior Principal Engineer at Pfizer
- Panel Discussion and Q&A
Derek Duncan•Michael Edey•Jackie Milne•Lisa BennettDerek Duncan
Director of Product Line at LIGHTHOUSEMichael Edey
Senior Principal Engineer at PfizerJackie Milne
Director, Process Development (Attribute Sciences) of AmgenLisa Bennett
Senior GMP Compliance Consultant & Trainer at SeerPharma
- Closing Remarks
Lisa Bennett•Bruce Loxley•Micheal Schafferius•Dinesh KhokalLisa Bennett
Senior GMP Compliance Consultant & Trainer at SeerPharmaBruce Loxley
Senior GMP Compliance Advisor at GlaxoSmithKline VaccinesMicheal Schafferius
Application Specialist at Sartorius AustraliaDinesh Khokal
Director, External Affairs, JAPAC and Intercontinental - LatAm of Amgen