Agenda

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

Featured Sessions

 

FDA Oversight of Drug Quality - Compliance
Oct 14, 2024 | 1630 - 1700
Presenter: FDA
Explore how the reconfigured quality assessment offices and research divisions are creating a more streamlined, agile, and flexible organization, reinforcing connections between assessment, inspection, surveillance, research, and policy operations. Delve into the reorganization of the Office of Regulatory Affairs into the Office of Inspectional and Investigations, aimed at reducing duplication and streamlining actions for greater clarity and promptness in enforcement. 
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:

  • Allen Koester
Mon, 14 Oct
1115 – 1145

Realizing Our Bold Sustainability Ambition

Sustainability - Supply Chain Resiliency
Kevin Conkright, AstraZeneca
Allen Koester, Salas O'Brien
Sustainability is a focus area in the pharmaceutical industry.  The pharmaceutical industry is a customer focused industry that puts its patients first.  A sustainable process is healthy for our environment.  A healthy environment supports a healthy patient.  AstraZeneca has a bold sustainability ambition which includes being carbon neutral by 2025.  Our presentation will display the journey of the Mt. Vernon AstraZeneca Supply Site to becoming a sustainable manufacturing facility achieving carbon neutrality by 2025.  This journey highlights a true corporate commitment, the role of technical partnerships, the importance of engaging your team across all levels, and of capitalizing on both big and small opportunities.
Kevin Conkright
Environmental & Sustainability Lead
AstraZeneca
Allen Koester
Senior Project Manager
Salas O'Brien

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.