Jörg Schiewe
Head of Global CMC Experts at Boehringer Ingelheim Pharma GmbH & Co. KG
Dr Jörg Schiewe is the Head of Global CMC Experts at Boehringer Ingelheim Pharma GmbH & Co. KG, Germany.
He studied chemistry at the Martin-Luther-University in Halle, Germany and earned his PhD in the field of physical chemistry in 1994. The Alexander von Humboldt foundation awarded Dr. Schiewe a Feodor-Lynen-Fellowship to perform post-doctoral work with Prof. Alan Bond at Monash University in Melbourne, Australia (1995-1997).
He joined Boehringer Ingelheim in 2000. In the past 20 years Dr. Schiewe was involved in the development of innovative inhalation products.
In his current position he contributes to cross-functional CMC development strategies and regulatory submissions to health care authorities.
Over the years Dr. Schiewe has done research work in the fields of physical chemistry, analytical chemistry and pharmaceutical sciences and published more than 30 scientific contributions including research articles, patents, book chapters and invited oral presentations.
Science base and challenges of therapeutic equivalence of respiratory products.
- What are the regulatory requirements for bioequivalence to bring respiratory products to the market? Why are the requirements of US FDA so different to that of the European Medicines Agency?
- Scientific basis for bioequivalence and therapeutic equivalence. Literature examples and case studies.
- Conclusion.