Parallel Session 1 - Implementing ICH Q12: Industry and Regulator's Experiences

Jan 24, 2023 10:30am ‐ Jan 24, 2023 12:00pm

Identification: 47653

While the implementation of ICH Q12 tools and enablers across the US, EU, Japan, Canada, Switzerland and other ICH member countries is under way, it is recognized that the global regulatory authorities are at different stages of incorporation of ICH Q12 principles and tools, which in itself can pose challenges. This session will be focused on real life examples pertaining to ECs, PACMPs, PLCM documents and the PQS from global ICH Q12 related pilot programs and submissions to health authorities to help understand the benefits and challenges associated with this enhanced framework. The understanding gained would facilitate effective, predictive management and operational flexibility of post-approval lifecycle changes thus enabling timely access of high quality, safe, and effective medicines to patients while reducing unnecessary cost, time, and burden on industry and regulators.

Technical Seminar Presented by Thermo Fisher Scientific

Jan 24, 2023 12:30pm ‐ Jan 24, 2023 1:30pm

Identification: 47656


Technical Seminar Presented by SCIEX

Jan 24, 2023 12:30pm ‐ Jan 24, 2023 1:30pm

Identification: 47657


Plenary Session 3 - Global Submissions and Regulatory Assessments: Towards Harmonized Approaches in the Regulation of Medicines to Patients

Jan 24, 2023 3:45pm ‐ Jan 24, 2023 5:15pm

Identification: 47665

The COVID-19 pandemic demonstrated that international collaboration among global regulatory authorities and with industry is essential, achievable and enables the best use of available resources and expertise. Regulators and industry collaborated to expedite product development and decision-making processes to enable treatment availability at an unprecedented pace, scale, and geographical reach.
What are our lessons learned? How can we leverage the experiences gained during the pandemic to streamline development, harmonize systems, and drive faster approvals to deliver quality medicines to more patients faster not only in preparation for the next pandemic but also as a new way of working?
This regulatory panel will bring together regulators from several global regions for an interactive discussion about evolving practices and initiatives to support agency-agency, agency-industry and industry-industry collaborations, including:
- Discussions on the role of regional and international harmonization and regulatory convergence initiatives, including a wider implementation of international guidelines e.g., ICH, WHO, and their updates to address advances in pharmaceutical science, technology, analytics, data management, and regulatory concepts
- Share experiences from collaborative reviews, e.g., ICMRA pilots, project Orbis/Access Consortium and other collaborative pathways, discuss traditional and alternative approaches to inspectional assessment, and outline next steps to foster the use of reliance pathways
- Explore how we can accelerate regulatory harmonization not only for initial marketing authorizations but also for post-approval changes to achieve the blue-sky vision “One dossier, one submission, one inspection, one approval”, e.g., ICH M4Q revision, CMC dossier content alignment, ICH Q12 benefits.




Session Panelists:

Samvel Azatyan, World Health Organization

Christopher Downey, CDER, FDA

Veronica Jekerle, European Medicines Agency

Ingrid Markovic, CBER, FDA

Elkiane Rama, ANVISA, Brazil

Dean Smith, Health Canada

Eric Karikari-Boateng, Food and Drugs Authority, Ghana

Yasuhiro Kishioka, PMDA-Pharmaceuticals and Medical Devices Agency, Japan

Global Submissions and Regulatory Assessments: Towards Harmonized Approaches in the Regulation of Medicines

Jan 24, 2023 3:45pm ‐ Jan 24, 2023 5:15pm

Identification: 471638 - 47665

The COVID-19 pandemic demonstrated that international collaboration among global regulatory authorities and with industry is essential, achievable and enables the best use of available resources and expertise. Regulators and industry collaborated to expedite streamlined product development and decision-making processes to enable treatment availability at an unprecedented pace, scale, and geographical reach.

What are our Lessons learned?  How can we leverage the experiences gained during the pandemic to streamline development, harmonize systems, and drive faster approvals to deliver quality medicines to more patients faster not only in preparation for the next pandemic but also as a new way of working? 

This regulatory panel will bring together regulators from several global regions for an interactive discussion about evolving practices and initiatives to support agency-agency, agency-industry and industry-industry collaborations, including: 

- Discussions on the role of regional and international harmonization and regulatory convergence initiatives, including a wider implementation of international guidelines, e.g., ICH, WHO, and their updates to address advances in pharmaceutical science, technology, analytics, data management, and regulatory concepts; 

- Share experiences from collaborative reviews, e.g., ICMRA pilots, projects ORBIS/ACCESS and other collaborative pathways, discuss traditional and alternative approaches to inspectional assessment, and outline next steps to foster the use of reliance pathways; and 

- Explore how we can accelerate regulatory harmonization not only for initial marketing authorizations but also for post-approval changes to achieve the blue-sky vision "One dossier, one submission, one inspection, one approval", e.g., ICH M4Q revision, CMC dossier content alignment, ICH Q12 benefits. 



Plenary Session 4 - Resolving Complexity: Innovative Analytical Technologies for Characterization of Complex Modalities

Jan 25, 2023 8:30am ‐ Jan 25, 2023 10:00am

Identification: 47880

In-depth analytical characterization of biological drugs and vaccines is important to aid in their development, and innovation in analytical technologies is crucial for the advancement of complex modalities. Biological therapeutic drugs and vaccines currently under development are often comprised of complex and multi-component/multi-functional modalities, that include multi-specific antibodies, antibody drug conjugates, conjugate and multicomponent vaccines, nucleic acid-based therapies and vaccines, genome editing therapies, viral vectors, cell therapies, blood products, and lipid-protein nanoparticles. The complexity of these modalities brings challenges to existing characterization approaches since different classes of biomolecules may require a diverse set of analytical methods for robust characterization. In addition, the large size and inherent structural heterogeneity of these modalities may lead to challenges in resolving product characteristics that may be relevant to clinical performance. Continuous innovation in the development of new analytical technologies and their application have enabled continued progress in the understanding of an ever-increasing array of these complex modalities. This session will focus on the technologies utilized for product characterization of complex modalities.

Parallel Session 5 - Innovations in Drug Delivery Technology to Enable the Next Generation of Biologics

Jan 25, 2023 10:30am ‐ Jan 25, 2023 12:00pm

Identification: 47883

Drug delivery technologies are evolving to support the delivery of drugs that balance enhanced safety and efficacy profiles with ease of use. With rapid evolution comes challenges to implementation of new devices and technologies. Existing quality systems, regulatory requirements and guidance’s may need to be revisited and adapted to future delivery technologies.

This session will dive into emerging drug delivery technologies and discuss considerations for implementing holistic control strategies, evaluate impact to Quality systems, and discuss regulatory requirements and pathways for these combination products. Opportunities and hurdles associated with implementing new device technologies within the current Quality and Regulatory systems and processes will be examined. 

Questions to be addressed in this session:


• What are some examples of new or emerging novel drug delivery technologies?
• What are the differences in the drug versus the device quality systems and what control strategies are employed relative to drugs versus devices and will these need to change as device technology changes?
• What regulatory challenges will occur when trying to introduce a new drug delivery technology? Will regulations and guidance’s need to change? How can regulatory updates or changes occur to match the rapid pace of device innovation and facilitate the implementation of new delivery technology that can benefit patients?

Parallel Session 6 - ICH Q14 and Q2(R2) Concepts and Enhanced Approaches to the Analytical Method Lifecycle

Jan 25, 2023 10:30am ‐ Jan 25, 2023 12:00pm

Identification: 47882

With the endorsement from ICH Management Committee in 2018 to introduce a new quality guideline for Analytical Development (ICH Q14) and a complementary revision of ICH Q2(R1) for Validation of Analytical Procedures, product owners will gain further guidance on enhanced approaches to analytical method development and validation. ICH Q14 will provide tools to harmonize scientific approaches for analytical method development. Currently, details of analytical development are not presented as part CTD Module 3 or other formal communications with regulatory agencies, unless to provide justifications for change category classification for post-approval changes of analytical procedures. Revisions to ICH Q2(R1) will provide a link to the Q14 principles and clarity in the existing guidelines for method validation and transfer as well as additional guidance for emerging analytical control techniques such as spectroscopic assays.
The development of a suitable analytical procedure requires understanding of product and processes, defining quality attributes of the active substance and selection of the right technology to deliver robust performance within an operating range. The combination of the proposed guidance may facilitate the selection and application of enhanced development approaches that could reduce the risk incurred by post-approval changes to analytical procedures discussed in ICHQ12: Pharmaceutical Product Lifecycle Management.
This session will focus on the concepts outlined in the new draft guidance ICH Q14 and revised ICHQ2 and enhanced approaches to the analytical method lifecycle using case studies and examples. Topics in scope include principles of the new guidance, accelerated development and post approval strategies, platform methods and leveraging prior knowledge.

Technical Seminar Sponsored by Cygnus Technologies

Jan 25, 2023 12:30pm ‐ Jan 25, 2023 1:30pm

Identification: 47886


Technical Seminar Sponsored by Bio-Techne

Jan 25, 2023 12:30pm ‐ Jan 25, 2023 1:30pm

Identification: 47885