DIA 2024 Global Annual Meeting

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-520-L04-P; CME 1.00; RN 1.00

The past decade has seen significant strides in machine learning and AI technologies. This session will provide an in depth investigate the various uses of machine learning and AI-based simulations within clinical development, ranging from data analysis, endpoint selection, the potential improvement of decision making within trial teams by clarifying tradeoffs to clinicians and statisticians, and more.

Learning Objectives

Describe the potential benefits of simulations in clinical trial protocol development and trial analysis, and the benefits of employing machine learning tools throughout clinical development; Discuss the novel approaches to conducting studies with such tools incorporated and relate to the regulatory guidance for adaptive trial design where relevant.

Chair

Raviv Pryluk, PhD

Speaker

Doing More with Less: Using ML to Drastically Improve Trial Simulation and Design
Raviv Pryluk, PhD

Clinical Trial Simulation: the Antidote to Wishful Thinking
Sam Miller, MSc

Digital Twins for Clinical Trials
Charles Fisher, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-526-L04-P; CME 1.00; RN 1.00

The session will share concrete experiences and expectations for the use of a single global dossier for CMC requirements. The panel will bring perspectives of regulators and industry, connecting the topic to regulatory convergence and reliance.

Learning Objectives

Identify the benefits of a single global dossier strategy for regulatory convergence and reliance initiatives in the area of CMC; Describe experiences from multinational companies with the implementation of harmonized dossier content for global submissions; Analyze and discuss the challenges and opportunities perceived by regulators for the use of a single global dossier for CMC requirements.

Chair

Ana Padua, MSc, RPh

Speaker

ICH M4Q(R2): Opportunity for One Global Dossier
Lawrence Yu, PhD

EMA Update
Evdokia Korakianiti, PhD, MSc

ANVISA Update
Nélio Cézar de Aquino, SR, MSc

Regional Regulatory Hub Strategist Team Lead: Specialty Care Portfolio LatAm
Agustin Brito Del Pino, RPh

Industry Update
Susanne Ausborn, PhD

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-567-L04-P; CME 1.00; RN 1.00

The session will provide an update on ICMRA's Pharmaceutical Quality Knowledge Management project, including an overview of learnings from the pilots on collaborative assessment of post-approval changes and hybrid inspections by multiple authorities.

Learning Objectives

Describe the various workstreams of the ICMRA PQKM project, and their potential to support increased regulatory convergence and reliance with regards to product quality assessments and inspections; Summarise learnings arising from the ICMRA pilots on collaborative assessment of post-approval changes and hybrid inspections; Discuss potential for expansion and operationalization of the pilots.

Chair

Theresa Mullin, PhD

Speaker

Collaborative Assessment Pilot: Regulators’ Perspective
Sau L Lee, PhD

Collaborative Assessment Pilot: Regulators’ Perspective
Sean Barry, PhD

Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Stelios Tsinontides, PhD, MA

Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Brendan Cuddy, MSc

Pilot Programs: Industry's Perspective
Susanne Ausborn, PhD

Pilot Programs: Industry's Perspectives
Srivdya Srikant, MS

Panel Discussion: Pilot Programs
Evdokia Korakianiti, PhD, MSc

Panel Discussion: Pilot Programs
Yasuhiro Kishioka, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-631-L04-P; CME 1.00; RN 1.00

This session aims to delve into WHO's pivotal role in the evolving landscape of global regulatory excellence. The discussion will revolve around the transformative impact of WHO-listed Authorities on medical product regulation, emphasizing regulatory reliance as a holistic approach to enhance efficiency and accessibility. Additionally, the session will address the pressing issue of substandard/falsified medical products and their potential threats to global health.

Learning Objectives

Describe the significance of WHO-listed Authorities in shaping the future of medical product regulation; Examine the concept of regulatory reliance as a key strategy to enhance access and efficiency in global regulatory practices; Discuss the critical role of regulatory excellence in safeguarding public health against the threats posed by substandard/falsified medical products.

Chair

Samvel Azatyan, MD, PhD

Speaker

Elevating Regulatory Reliance: The Strategic Impact of WHO-Listed Authorities in Transforming Global Regulatory Landscapes
Hiiti Sillo, MSc, RPh

Securing Supply Chains: A Global Imperative
Rutendo Kuwana, RPh

EMA Update
Emer Cooke, MBA, MSc

Industry Update
Janis Bernat, MSc

Moderator for Panel Discussion and Q&A
Marion Laumonier, MSc

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-644-L04-P; CME 1.00; RN 1.00

In this session, we will discuss international efforts to promote regulatory convergence and expand the use of reliance to bring these highly complex therapies to market earlier, particularly in less developed countries.

Learning Objectives

Describe how international harmonization, collaboration, and reliance principles can be effectively applied to the regulation of cell and gene therapies; Discuss the key considerations and regulatory challenges associated with bringing complex, innovative medicines such as cell and gene therapy products to less experienced, emerging markets.

Chair

Ginny Beakes-Read, BSN, JD

Speaker

FDA Update
Julia Tierney, JD

WHO Update
Samvel Azatyan, MD, PhD

PMDA Update
Yasuhiro Kishioka, PhD

Industry Update
Maria Antonieta Tony Roman, MPharm

EMA Update
Anabela Marcal, PharmD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-671-L04-P; CME 1.00; RN 1.00

This forum will discuss regulatory activities and technology to enable global convergence and reliance for post-approval changes (PAC). Diverse panelists will share examples of efficient collaboration and information exchange to reduce the PAC process cycle times.

Learning Objectives

Recognize the importance of global collaboration to support sovereign decision making; Discuss how building in reliance practices into cloud-based solutions could accelerate the post-approve changes (PAC) process globally; Explain how cloud solutions support transparency, trust, regulatory convergence, and information exchange, and collaboration to increase patient access to therapies.

Chair

Dominique Lagrave, PharmD

Speaker

Panelist
Samvel Azatyan, MD, PhD

Panelist
David Mukanga, PhD, MPH

Panelist
Susanne Ausborn, PhD

Panelist
Cynthia Ban

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-688-L04-P; CME 1.00; RN 1.00

Challenges remain in the implementation of reliance. This session will bring together stakeholders to discuss the utilisation of assessment reports, and recommend ways to ensure effective and efficient systems in the future.

Learning Objectives

Recognize the value of assessment reports in enabling reliance; Describe current use of public and non-public information for enabling regulatory reviews; Discuss how documentation and information sharing could improve to ensure reliance becomes successful.

Chair

Magda Bujar, PhD, MSc

Speaker

WHO Update
Samvel Azatyan, MD, PhD

Reference Agency Viewpoint
Emer Cooke, MBA, MSc

Relying Agency Viewpoint
Patricia Oliveira Pereira Tagliari, LLM, MPH

Industry Viewpoint
Susanne Ausborn, PhD