Featured speakers at the 2024 ISPE Aseptic Conference will be health representatives from Australia, Europe, and the US.
The representatives from these national regulatory agencies will discuss current issues in aseptic processing from a technical perspective and the latest developments in aseptic and sterile manufacturing.
These featured speakers will also provide clarifications and weigh in on key learnings from the initial steps towards the implementation of Annex 1.
Attendees will have the opportunity to submit questions to the panellists.
The featured speakers are representatives from the following:
- Austrian Agency for Health and Food Safety (AGES/Austria)
- Regierungspraesidium (RP) Tübingen in Germany
- Swissmedic in Switzerland
- Therapeutic Goods Administration (TGA) in Australia
- United States Food and Drug Administration (US FDA).
The confirmed featured speakers are:
- Christina Meissner, GMP Inspector at the Austrian Agency for Health and Food Safety (AGES)
Meissner said: “As a representative of the Austrian Competent Authority, I will be reporting on the status of the implementation of Annex 1."
“There will be specific examples of best practices, but also of areas where the industry needs to improve,” Meissner continued.
- Daniel Muller, Head of GMP Inspectorate at Regierungspraesidium (RP) Tübingen in Germany
Muller said: “As a German regulator, I will be talking about our experiences in inspections since Annex 1 came into effect in August 2023.”
Muller will be discussing the areas where RP have seen good strategies of implementation, common hurdles for implementation, and where the industry has to improve.
- Maria Löflund, Site Head Manufacturing Vienna at Takeda
Löflund said: “ISPE provides a great platform for exchanging knowledge and best practices with other companies on current and important industry topics.”
“I am looking forward to the 2024 ISPE Aseptic Conference in March and the valuable discussions on aseptic processing and implications of Annex 1 changes to the industry, as well as welcoming visitors to our Takeda production site in Vienna to share insights into our technologies and processes,” Löflund added.
- Alexander Herzog, Secretary General of PHARMIG in Austria
Herzog said: “My talk will focus on the contribution of the pharmaceutical industry in Austria to world health.”
The 2024 ISPE Aseptic Conference will bring together leading professionals from several industries including:
- Pharmaceutical and biopharmaceutical manufacturers
- Technology providers
- Academic scientists
- International regulators