Past events

Online PharmaTalk 2/2021

Speaker: Ashutosh Rao, Ph.D., Center for Drug Evaluation and Research, U.S. Food and Drug Administration Topic: «Scientific and regulatory perspectives on control strategies for excipients in biotechnology drugs» Date, time: Fri May 7, 2021, 14:00 – 15 h Mode: Online Webinar, Zoom link Abstract: Surfactants and other excipients are an integral component of biotechnology drug products. Consequently, optimal formulation and control of excipients are key aspects of an overall control strategy by drug manufacturers aimed at consistent product quality, safety, and efficacy. Evolving evidence suggests that certain surfactants are susceptible to degradation and particulate formation in protein formulations; although, the root cause, biochemical drivers of degradation, and impact to the product and patient remain unresolved questions.  The regulatory basis for the U.S. FDA’s expectations on the quality and analysis of excipients during drug development is primarily derived from 21 CFR 211.84(6)(d)(2). The overall control strategy and other information submitted by the drug developer is generally expected to address unreasonable and significant risk of illness or injury to human subjects as well as to provide sufficient information to allow regulators to assess potential risk to human subjects. This presentation will cover (1) the current scientific and regulatory rationale for using and controlling surfactants in protein formulations, (2) a pragmatic overview of the risk from surfactant degradation, (3) orthogonal strategies for controlling surfactant, host cell proteins, and related product quality attributes such as particulates in therapeutic proteins, (4) the types of studies that generally support the safe use of surfactants in protein formulations, and (5) the desired state of surfactant and related product quality attributes.

12th Swiss Pharma Science Day 2019

Date, place: Wednesday August 28 2019, Langhans Auditory Pathology, University Hospital Bern Topic: «Diabetes» Program: sphsd_2019_program_final.pdf Conference booklet: sphsd_2019_conf_book_final.pdf Conference report: sphsd_2019_conference_report.pdf Evaluation (online): surveymonkey_results.pdf

Swiss Pharma Science Day 2018

11th Swiss Pharma Science Day 2018 Date and place: Wednesday August 22, 2018, University of Bern, Langhans Auditory Pathology Program: sphsd_2018_program_final.pdf Poster: sphsd_2018_poster.pdf Conference Booklet: sphsd_2018_conf_book.pdf Lectures: l-1_rothlisberger.pdf; l-2_mcneil.pdf; l-3_rauh.pdf; l-5_schneider.pdf Conference Report: sphsd_2018_conference_report.pdf

10. Anniversary Swiss Pharma Science Day 2017

Conference Booklet with lecture and poster abstracts: sphsd_2017_conf_book_final.pdf PDF of lectures for free download: meier.pdf, wang.pdf, bazile.pdf, fellmann.pdf Conference report: sphsd_2017_conference_report.pdf Conference report pharmaJournal (D, F): sphsd_2017_conference_report_pharmajournal_de.pdf, sphsd_2017_conference_report_pharmajournal_fr.pdf Fotos: Foto Gallery

Joint Meeting SAPhW-OePhG: PHARMA 2030 – CURRENT AND FUTURE CHALLENGES

Preannouncement:
Place and date: Universität Innsbruck, 20. – 22. April 2017
2nd Announcement: second_announcement.pdf
Registration: https://www.uibk.ac.at/congress/pharma-2030/registration.html

Meeting SAPhW Fellows 2017 - "Science in Pharmacy, Pharmacy in Science"

House of the University of Bern, April 18, 2017, 12.30 - 15.45 h Topic: «Science in Pharmacy, Pharmacy in Science» Program: follow_up_meeting_program_final.pdf For PDFs of all presentations see website version DE  

9. Swiss Pharma Science Day 2016

Wednesday August 31, 2016, Inselspital-University Hospital Bern Program: sphsd_2016_program.pdf Poster: sphsd_2016_poster.pdf Conference Book (program, abstracts of lectures and posters, participants): conference_book_2016.pdf

Trends in Pharmaceutical Sciences

Prof. Dr. Georg Imanidis, University of Applied Sciences Northwestern Switzerland FHNW, School of Life Sciences, Institute of Pharma Technology "Lehre und Forschung in pharmazeutischer Technologie an der Hochschule für (industrielle) Life Sciences - FHNW" imanidis_fhnw_2016-04-20.pdf

Swiss Pharma Science Day 2015

7. Swiss Pharma Science Day (SPhSD) 2014

Dr. Hans. H. Schicht, Contamination Control Consulting Zumikon: " Contamination Control in der Pharmaherstellung - Fragen und Antworten"

Malcolm Ross, Generapharm Training and Consultancy: "The effect of cultural differences in the pharmaceutical environment" www.generapharm.eu Präsentation: http://www.saphw.ch/sites/default/files/attachments/cultural_differences...