Agenda

Our education program offers cutting-edge technical sessions, shedding light on the latest advancements in the pharma industry.

Featured Sessions

 

Unpacking Recent ICH Guidelines
Oct 15, 2024 | 1530 - 1700
Presenters: Multiple
Join us at the Global Implementation Strategies Forum to engage with industry experts and regulators on the Global Adoption Status and Implementation Strategies for ICH Q2(R2)/Q14 and Q12 guidelines. Discover how these science- and risk-based approaches to lifecycle management are ensuring the continued quality of drug substances and drug products worldwide. Explore how ICH Q12 provides tools for effective post-approval change management and regulatory reporting, while ICH Q2(R2)/Q14 focuses on the development, validation, and lifecycle of analytical procedures. 
ISPE Regulatory
Town Hall
Oct 16, 2024 | 0950 - 1120
Presenters: Multiple
Join us at the Regulatory Town Hall where you can engage with International Regulators and Industry thought leaders on topics including progress on Mutual Reliance, new methodologies on information sharing between industry and regulators, new product development paradigms, the use of mechanistic models to support physiologically based pharmacokinetics useful in product development and evaluations of medicines and vaccines. 

All session times are listed in Eastern Time (ET). Find your personal viewing time on the World Clock.

Speakers

Selected filters:

  • Eric. Staib
Mon, 14 Oct
1015 – 1045

Overcoming Challenges of Digital Innovation (AI)

Digital Transformation
Brandi Stockton, The Triality Group, LLC
Eric. Staib, Syneos Health
Integration of AI brings inherent challenges that must be understood for effective digital innovation.  The inherent challenges range from availability and governance of data to the need for agile development processes and organizational change management.  In response to such challenges, identification of strategies and best practices is essential and should include such things as data governance frameworks, promoting diversity in both training data and development teams, adopting flexible methodologies to accommodate the iterative nature of AI.  Learning to effectively implement AI involves not only technical expertise but also an organizational culture that supports experimentation and continuous improvement. This includes a cross-disciplinary approach leveraging insights from data scientists, IT, business stakeholders, and the quality organization to ensure the AI enabled technologies are aligned with objectives of the business, are ethically and responsibly integrated into operations.
Brandi Stockton
Founder | Managing Partner
The Triality Group, LLC
Eric. Staib
Vice President, Corporate Quality
Syneos Health

Hear From Top Industry Thought Leaders and Regulators on the Challenges and Solutions Impacting the Pharmaceutical Industry

Speaker Qualifications

Speakers selected to present at ISPE events are leading professionals in their fields. However, it may be necessary to make substitutions. Every possible effort will be made to substitute a speaker with comparable qualifications. Every precaution is taken to ensure accuracy. ISPE does not assume responsibility for information distributed or contained in these events, or for any opinion expressed.

Agenda Changes

Agenda is subject to change. Last minute changes due to functional, private, or organizational needs may be necessary. The event organizer accepts no liability for any additional costs caused by a change of the agenda.