2023 ISPE Pharma 4.0™ and Annex 1 Conference


The 2023 ISPE Pharma 4.0™ and Annex 1 Conference will bring together leading pharmaceutical and biopharmaceutical manufacturers, technology providers, academic scientists, and international regulators to network, share insights and provide an outlook on the evolving landscape and future of Pharma 4.0™ supported Aseptic Manufacturing.

The conference will provide a leading interdisciplinary platform for all stakeholders of the pharmaceutical chain. This platform will showcase recent innovations and trends, and directly discuss practical challenges and solutions from a technical, logistical, and regulatory perspective. The impact of upcoming regulations, in particular for Annex 1, will be integrated throughout the conference programme and panel discussions. Participants will have the opportunity to engage with industry leaders, regulators, and peers through networking events and the conference programme.

Call for Proposals Timeline

  • Submission Opens
  • Submission Deadline
  • Notifications Sent

Proposals are Closed!

Requested Submission Topics 

Given the impact of the evolving pandemic, an aging population, the increase in diseases with unmet needs, and an unprecedented rise in chronic diseases, the need for a constant focus on collaborative innovation and agility will shape Pharma’s priorities in the foreseeable future. ISPE will be the leader to set the pace for knowledge sharing that speaks to the current and future needs of the industry. 

The 2023 ISPE Pharma 4.0™ and Annex 1 reviewers are requesting proposals aligning with the following content areas:

Proposal Submission Type

Individual Oral Presentation

20-minute presentation, to be made part of a larger session by the Planning Committee. The presentation should focus on new and innovative trends, a specific real-world strategy or campaign, a case study/use case, or a “how-to" presentation intended to help attendees gain a better understanding of the initiative and best practices that can be applied to day-to-day objectives or overall mission.

Proposal Guidelines

  • All presentations must be free of commercial intent. Incomplete proposals will not be considered.
  • By submitting a proposal, you acknowledge that, if your proposal is accepted, the speaker will attend/present in-person at the event and their organization will support the speaker’s attendance at the event.
  • Accepted speakers are responsible for their own travel and accommodations.
  • Speakers giving at least a 20-minute presentation (not including Q&A) receive complimentary conference registration.
  • NOTE: Exhibitors who are accepted to present are required to register as a paid conference attendee (with 20% discount off the prevailing registration rate). Complimentary booth staffing registrations cannot be utilized for the presentations as these are part of the education sessions and not the exhibition.
  • Consulting firms or vendors/suppliers are expected to include a speaker from an owner company to present.
  • Regulators interested in submitting a proposal: Please contact Brandy Berry to submit your abstract.

Programme Committee

Cristina Mazo
QP - Site Manager
GP Pharma
Chair - Pharma 4.0
Vice President Vetter Development Service External Affairs
Vetter Pharma Fertigung GmbH & Co KG
Chair - Annex 1
Nuha Al-Hafez
Quality Fundamentals Area Lead
Richard DENK
Senior Consultant Aseptic Processing & Containment
Yvonne Duckworth, PE
Fellow - Digital Technology, Associate
Jean Francois DULIERE
Reg Advisor
Matthew P. Gorton
Director of Business Development
GBA Life Sciences
Felix Kern
Associate Director - Head of Compliance Launch and Technology Center
Merck KGaA
Line Lundsberg-Nielsen, PhD
Managing Consultant, Compliance Consulting
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Heike Roeder
Vice President QA International
Alicia Tebar
Founder. QbD & GMP Consultant
QbD Pharmaceutical Services SL
Head of MSci Innovation
Takeda Pharmaceutical International AG
Wolfgang WINTER
Software Framework R&D Director
Agilent Technologies Deutschland GmbH
Christian Woelbeling
Executive Industry Advisor
Körber Pharma Software GmbH