Courses "GxP in biomedical research"

21-22 July 2015, Bonn, Germany

July 21, 2015

There are short breaks (15 min each) planned, but not indicated

Univ. - Prof. Dr. Harald G. Schweim (RFWU-Bonn)

09:00 – 10:00 A1 DRA Introduction in Regulatory Topics in Biomedical Research

Dir. u. Prof. Dr. Usfeya Muazzam (formerly BfArM-Bonn)

10:00 – 11:00 B2 GMP (What? Why? How? Directives. ICH Q7, Q9, Q10)
11:00 – 12:00 B3 GMP (Quality without compromise - how? Quality improvement.)
12:00 – 13:00 B4 GMP (Compliance. Inspections. Deficiencies.)

Prof. Dr. Jürgen Pomp (Hochschule Bonn Rhein-Sieg)

14:00 – 15:00 C5 GLP basics (laws, regulations, focus)
15:00 – 15:00 C6 GLP Test facility (Laboratory, units, roles and responsibilities)
16:00 – 17:00 C7 GLP SOP system (Establishing and maintenance of the SOPs)
17:00 – 18:00 C8 GLP Training and mentor system

July 22, 2015

Prof. Dr. Jürgen Pomp (Hochschule Bonn Rhein-Sieg)

08:00 – 09:00 C09 GLP Planning and conduct of GLP studies (from study protocol to archive)
09:00 – 10:00 C10 GLP Testing equipment and computers under GLP, incl. practical examples
10:00 – 11:00 C11 GLP Documentation and archiving (good documentation practice), incl. practical examples
11:00 – 12:00 C12 GLP Audits and inspections (internal, external, authority inspection)

Continued with the official PHYTOPHARM –Program first day (Regulatory lectures):

Prof. Rudolf Bauer, University of Graz, Austria: "The development of medicinal plant research from botany to systems biology.”

Dr. Jinhu Dou, Acting Team Leader for Botanical Review Team FDA, USA:"FDA policy on the US Clinical Trials for Botanicals”

Prof. Werner Knoess, Federal Institute for Drugs and Medical Devices, Bonn, Germany, "Har- monized assessment of (traditional) herbal medicinal products in the European Union - achieve- ments and future challenges".

Prof. Johannes Novak, University of Veterinary Medicine, Vienna, Austria, "Good acricultural and wild collection practice of medicinal and aromatic plants".

Second day: (Regulatory lectures)

Prof. Konstantin Eller, Institute of Nutrition of Russian Academy of medical sciences, Mos- cow, Russia "The role of the contemporary analytical methodology in the estimation of biologi- cal value of raw materials from wild growing medicinal and food plants"

Prof. Harald Schweim, Drug Regulatory Affairs, University of Bonn, Germany, "Status quo and future developments of combination medicinal products"

Dr. Elizabeth Dauncey, Royal Botanic Gardens, Kew, UK. "Kew’s Medicinal Plant Names Services and their role in the safety and efficacy of plant-based medicines"

Dr. Kenny Kuchta, National Institute of Health Sciences, Tokyo, Japan, "How to receive regu- latory approval in Japan for Western herbal medicinal products"

Attorney Alexander Maur, Kanzlei am Aerztehaus, Frehse Mack Vogelsang, Cologne, Germa- ny, "Demarcation between phytopharmaceutics and neighboring product categories in the EU – demarcation criteria and regulatory consequences"

Attorney Janna K. Schweim, MSc, Kanzlei J. Schweim, Köln, Visiting Scientist Univ.-Bonn, Germany, "Comparison and differentiation between clinical trials with medicinal products and scientific studies with nutritional products"