DIA 2024 Global Annual Meeting

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: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-539-L04-P; CME 1.00; RN 1.00

Explore US and EU AI drug regulation with experts from regulator, industry, and academic perspectives. Learn about principles, data privacy, transparency, and real-world examples. Gain insights into vital regulatory nuances.

Learning Objectives

Describe the regulatory frameworks in the US and EU; Discuss the practical necessity of regulation in various AI-driven drug development scenarios.

Chair

Jayne Ware, MPH, MSc

Speaker

EMA Update
Steffen Thirstrup, MD, PhD

FDA Update
Tala Fakhouri, PhD, MPH

Industry Perspective
Rose Purcell, JD, MA

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-543-L04-P; CME 1.00; RN 1.00

The current paradigm of repeated safety report transmission to multiple regulators results in greater noise, duplicative effort, more lag time, and diverted focus from protecting patients and building trust through a shared proactive safety science. Might international collaboration evolve in this era of real-world evidence to no longer require such continual circulation of the same adverse event reports? Might newer technologies be leveraged for a more effective modern system? What are the options and the issues that would need to be considered to realize this future state? A panel of regulators and international stakeholders will discuss the issues.

Learning Objectives

Identify the issue and extent of international replication of safety reports; Discuss the possibility of leveraging modern processes or technical solutions (e.g., blockchain or decentralized networks) to enable more effective international collaboration; Determine how to move this agenda forward by focusing on patient safety in light of challenges and opportunities.

Chair

Andrew Bate, PhD, MA

Speaker

Paradigm Shift in Adverse Event Report Management and Sharing: Industry Update
Mayur A Patel, PharmD

Regulatory Perspective on AE Report Management and Sharing and Future Directions
Phil Tregunno

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-558-L04-P; CME 1.00; RN 1.00

In 2021, recommendations to reduce site feasibility assessment burdens was released.. Current industry and CRO methods remain costly and inefficient, and delay trial start-up and patient access to clinical trials.

Learning Objectives

Describe the impact of non-standardized study feasibility assessments across the industry; Discuss opportunities and solutions around improvements to the site feasibility assessment process; Apply new methods to streamline feasibility assessments and improve study start-up timelines.

Chair

Trevor Joseph Cole, MBA, RN, PMP

Speaker

Panelist
Kristen Ballesteros, PhD, MS

Panelist
Suanna S. Bruinooge, MPH

Panelist
Ramya Thota

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-569-L04-P; CME 1.00; RN 1.00

This forum will hear from regulators, industry, vendors, and the academic community on how each has approached the generation of long-term safety data on a hypothetical approved medicine with a risk of delayed adverse events.

Learning Objectives

Compare strengths and weaknesses of different approaches for evaluating long-term safety particularly when delayed adverse events are a potential risk; Identify fit-for-purpose, longitudinal data sources to answer regulator research objectives for long-term follow-up studies.

Chair

Steven M. Weisman, PhD

Speaker

Panelist
Claudia A Salinas, PhD

Panelist
Naomi Boxall, PhD

Panelist
Vera Ehrenstein, DrSc, MPH

Panelist
Gerald Dal Pan, MD, MHS

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-594-L04-P; CME 1.00; RN 1.00

Since establishment in 1990, the International Council for Harmonisation (ICH) has expanded its global footprint to harmonize requirements for the development of medicines and to increase patient access to medicines. Importantly, ICH’s quality portfolio serves to support continual improvement and innovation in biopharmaceutical manufacturing. In 2018, ICH published its quality mission to “develop a harmonised pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science” driving the development of several new guidelines addressing topics on lifecycle management, quality risk management, continuous manufacturing, and analytical procedure development and validation. With ICH’s expansion, it has prioritized the adequate implementation and adherence of guidelines through its work to promote training and periodically conduct a survey to assess guideline implementation by ICH Members and Observers. This session will provide global regulatory and industry perspective regarding progress made on the ICH quality mission and explore future opportunities to achieve greater harmonization and encourage the global community to embrace the science and risk-based approaches. Case studies will be presented highlighting the objectives and work to facilitate a globally aligned approach to implementation of ICH guidelines.

Learning Objectives

Describe objectives of international harmonization through ICH to promote innovation and facilitate more efficient lifecycle and post-approval change management; Discuss status of key ICH Guidelines such as Q13, Q12 and Q14 and their implementation globally; Evaluate case studies and identify opportunities to advance global harmonization.

Chair

Amanda Marie Roache, MS

Speaker

Lifecycle Strategies at the Interface Between ICH Q12 and ICH Q14
Connie Langer, MSc

ICH Q14: Analytical Procedure Development and Lifecycle Management
Nina S. Cauchon, PhD

FDA Update
Sau L Lee, PhD

Update from Japan on Q12
Satomi Yagi

Update from EMA
Anabela Marcal, PharmD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-606-L04-P; CME 1.00; RN 1.00

Industry leaders will discuss how regulatory and industrial policy can support delivering quality-assured medicines to patients faster, how to assure pharmaceutical quality for innovative and generic medicines especially in light of new analytical technologies, and how to evaluate potential threats to quality in the context of benefit-risk and patient access.

Learning Objectives

Define quality management maturity (QMM) and how the government is proposing to use it to improve the quality of medicines and resiliency of the supply chain; Identify policy solutions to quality challenges like nitrosamines, PFAS, and related impurities/chemicals; Understand the role of third parties like USP in defining quality standards; Comprehend policy ideas that enable earlier patient access to medicines without compromising quality

Chair

Aaron Josephson, MS

Speaker

How to Integrate Quality Management Maturity into Regulatory Assessment and Oversight
Aaron Josephson, MS

Global Landscape of Emerging Impurity and Chemicals Challenges
Katherine Wilson, JD, MA

Quality Policy Priorities of the Canadian Generic Industry
Kristin Willemsen, MS

The Changing Pharmaceutical Quality Landscape – Pharmacopeial Perspective
Brett Howard, JD, PhD

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-610-L04-P; CME 1.00; RN 1.00

Pregnant individuals are underrepresented in research. This session provides an overview of how the evolving regulatory framework, pharmaco-epidemiology, and clinical trials can advance evidence generation and contribute to pregnancy labeling.

Learning Objectives

Discuss important global advances in the collection of data in drugs and biological products used during pregnancy; Identify the evolving regulatory framework, and the value of premarket and postmarketing safety data that can lead to improved labeling information for drugs and biological products used in pregnancy; Describe stakeholder efforts to include pregnant individuals in clinical trials.

Chair

Martine Dehlinger-Kremer, PhD

Speaker

Assessment of Drugs Used During Pregnancy: Current Status
Martine Dehlinger-Kremer, PhD

Safety of Drugs Used During Pregnancy: Regulatory Considerations and Updates
Lynne Yao, MD

Post-Marketing Approval Safety Studies: The Role of Pregnancy Registries
Christina Chambers, PhD, MPH

Evaluation of Drug Use During Pregnancy: Post-Marketing Surveillance and Beyond - Time for a Paradigm Shift
Laura Shaughnessy, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-633-L04-P; CME 1.00; RN 1.00

This forum session will explore the transformative potential of Artificial Intelligence (AI) in biotech RA CMC and advanced manufacturing. Discover how AI can optimize processes, improve efficiency, and ensure compliance of your data.

Learning Objectives

Define key concepts and principles of artificial intelligence (AI) in the context of biotech industry, regulatory CMC and advanced manufacturing; Identify the potential applications and benefits of AI including how it can automate deviation and change control processes or support strategic decision-making; Discuss the benefits, challenges and cons of AI i.e. data integrity and security.

Chair

Grzegorz (Greg) Podrygajlo, PhD

Speaker

Introduction
Demetra Macheras, MBA

Application of AI Tools to Support the Decision Process in Regulatory CMC
Grzegorz (Greg) Podrygajlo, PhD

Use of AI and ML in Pharmaceutical Manufacturing: Case Studies from the Shop Floor and Regulatory Landscape
Gert Thurau, DrSc, PhD

How to Use GenAI in a Smart Way for Now and for the Future
Hubert Niewiadomski, PhD

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: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-649-L04-P; CME 1.00; RN 1.00

The clinical research workforce crisis threatens to undermine the entire drug development ecosystem. This session will discuss the glaring disconnect between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that’s in dire straits. It will feature a variety of industry leaders who will frame the issue and share lessons, solutions, and workforce development models that can be emulated globally to help build the next generation of clinical researchers--diverse and research ready.

Learning Objectives

Discuss the extent of the clinical research workforce crisis, including a diminishing pool of experienced clinical research professionals a ‘war for talent’ that is driving high and unsustainable turnover; Identify factors contributing to this crisis; Describe promising steps that can help with future workforce development.

Chair

Susan Landis

Speaker

Panelist Speaker
Marlena Jackson

Industry Update
Jimmy Bechtel, MBA

Speaker
Doug Peddicord, PhD

Academic Update
Jonathan Watanabe, PharmD, PhD

Panelist
Martine Dehlinger-Kremer, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-659-L04-P; CME 1.00; RN 1.00

A number of questions remain about Safety Surveillance Plans (SSPs). The proposed panel discussion will include persons from multiple sponsors who have experience with developing processes to address the FDA’s recommendations in the 2021 guidance.

Learning Objectives

Discuss when a safety surveillance plan (SSP) is warranted; Describe specifics on implementation of the trigger method; Evaluate a product in different patient populations and ensure study integrity; Identify clarity on roles and responsibilities to data monitoring committee members (or other entities) who are making recommendations to the sponsor regarding IND safety reporting.

Chair

Greg Ball, PhD

Speaker

Panelist
Susan Talbot, MSc

Panelist
Ranjeeta Sinvhal, MD

Panelist
Susan Kindig, JD, MD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-694-L04-P; CME 1.00; RN 1.00

In this forum, regulatory authorities from the Middle East and Africa region will share updates, success stories, lessons learned and plans for the future.

Learning Objectives

Identify the regulatory authorities' representatives from the Middle East and Africa region; Discuss new developments and opportunities in the region.

Speaker

Moderator
Eli Weinberg, PhD, MS

Panelist
Inas Chehimi

Panelist
David Mukanga, PhD, MPH

Panelist
Ashraf El Fiky

Panelist
Mahmoud Fahmy Elsabahy, PhD

Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-677-L04-P; CME 1.00; RN 1.00

Session will focus on considerations when using real-world data for post-marketing safety studies, with use cases provided.

Learning Objectives

Identify specific study design and analytic challenges related to the safety of medical products, with a focus on rheumatology and ophthalmology; Describe key elements to consider when identifying real-world data sources to generate real-world evidence.

Chair

Alicia Gilsenan, PhD, MS, RPh, FISPE

Speaker

FDA RWE Program and Considerations in Assessing Validity of Safety Studies using RWD
Marie Bradley, PhD, MPH, MPharm

Value of Real-World Data/Real-World Evidence to Assess Post-marketing Safety: Use Case- Ophthalmology
Angelika Manthripragada, PhD, MPH

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

Reference Agency Viewpoint
Emer Cooke, MBA, MSc

Relying Agency Viewpoint
Patricia Oliveira Pereira Tagliari, LLM, MPH

Industry Viewpoint
Susanne Ausborn, PhD

WHO Update
Samvel Azatyan, MD, PhD