Agenda

1300 – 1600

Practical Implementation of Digital Transformation

Workshops

Andrew Palm, Pfizer

Organizations seeking to keep up with the digital transformation are investing in new technologies with an end-to-end (E2E) focus on their products and processes, aiming to improve operational excellence, worker experience, product quality and delivery timelines. Adoption of these new technologies requires a systematic, structural, and holistic transformation of individuals and the organization. Smart organizations of today and the future need to effectively capture, maintain and share their data, information and knowledge - including their people’s implicit and tacit knowledge - to maintain a competitive advantage and meet these high demands. This workshop is a continuation of the European Annual Meeting Workshop and will include learnings and output from attendees. As well, comparisons from US and European attendees’ experiences will be made to benefit future ISPE content.

Andrew Palm

Director, Integrated Process Analytics
Pfizer

1300 – 1600

Technology in Alignment with EU Guidance & eClinical GPG

Workshops

Petch Ashida Druar, Syneos Health

In light of the requirements discussed within the EU Guideline on computerised systems and electronic data in clinical trials and the information provided within the new GAMP Good eClinical Practice guide the workshop will explore challenges with implementing new technologies used in support of clinical trials, e.g.
1. Decentralized Clinical Trials- Risks and concerns with the use of eClinical Platforms, e.g., ePRO, eCOA, IRT/RTSM; Roles and responsibilities for systems and validation; challenges in distribution of IMP; BYOD
2. Good Clinical Laboratory Practice- Consider the risks and concerns with the use of partners; data transfer; systems and validation
3. Data Science and AI-Enabled systems
4. Real World Data / Real World Evidence.

Petch Ashida Druar

Director, Computer Systems Quality and Data Integrity
Syneos Health

1300 – 1600

Robust Quality Management Maturity: APQ and FDA

Workshops

Thomas Friedli, University of St.Gallen

Tami Frederick, Perrigo

The ISPE Advancing Pharmaceutical Quality (APQ) Program has been developed by industry representatives, for industry use, to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System (PQS). The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself and a key driver for this program is to provide a range of sustainable and practical quality management improvement strategies.This ISPE Advancing Pharmaceutical Quality Program is intended to provide a practical framework that an organization can use to first assess the maturity and then advance the state of quality within their organization. It is a quality management maturity program that aims to identify good practices and good behaviors which support the continual improvement of quality management effectiveness within an organization. The Advancing Pharmaceutical Quality (APQ) Program provides specific guidance on how to assess and improve each element of the Pharmaceutical Quality System using the new APQ Assess, Aspire, Act & Advance Framework. APQ includes practical tools, comprising of both quantitative and qualitative assessment criteria, against which the effectiveness of the pharmaceutical quality system can be evaluated and then improved upon.

Thomas Friedli

Professor and Director
University of St.Gallen

Tami Frederick

Senior Director, Corporate Quality Systems & Cultural Excellence
Perrigo

1300 – 1600

Optimizing Cost of Goods for Cell Therapy Production

Workshops

Ken Rando, COMECER

Erich Bozenhardt, United Therapeutics

Optimizing Cost of Goods for Cell Therapy Production--Current and Future Tools for Consideration This session will present two case study vignettes where companies used the Baseline Guide concepts to form the basis of design for a new manufacturing asset. The case studies focus on key Guide principles that identify the synergies between process closure, operation efficiency, contamination risk mitigation, and facility optimization. Specific references to the Guide will be provided as part of the interaction with the Audience.