Dr. Stefan Leiner, Boehringer Ingelheim - Qepler Summits And Conferences

Dr. Stefan Leiner

Chemical-Pharmaceutical Expert
Boehringer Ingelheim
Germany
Boehringer Ingelheim is a global, research-driven pharmaceutical company embracing many cultures and diverse societies.

Dr. Stefan Leiner is a pharmacist by training and joined Boehringer Ingelheim in Germany in 1987. After a couple of years in manufacture, pharmaceutical and analytical development, he focussed on inhalation forms.

He is responsible for the scientific standard of the Module 3 of Marketing Authorisation Applications. He authored the Quality Overall Summaries for many of Boehringer Ingelheim’s inhalation developments.

Stefan Leiner represents Boehringer Ingelheim in the International Pharmaceutical Aerosol Consortium - Regulation and Science (IPAC-RS) and was chair of that organisation. He was member of the development group of the ISO 20072 Standard on «Aerosol Drug Delivery Devices». He is active in pharmacopoeias.

Related Sessions:

Inhaled Drug Delivery
Summit 2019

Assess and harness novel approaches to the development of inhaled drug products for enhanced patient care.
  • 27 Feb 2019
  • Berlin, DE
  • Pharma
Day 1: Wednesday, 27 February 2019
BLOCK: REGULATORY UPDATES.
CASE STUDY: Clash of the cultures: Requirements for inhalation bioequivalence – contrasts between US, EU, Australia, Japan, Brazil.
  • Which regulations exist in US, EU and other countries?
  • What are the differences between US and EU requirements for bioequivalence of inhalation products?
  • Why are there such differences?
  • Is harmonization possible?
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