Publications

Our know-how is in high demand

The YES employees are frequently asked to contribute articles to specialist magazines and periodicals. The focus here is on regulatory issues and development projects. Some examples are listed below. For copyright reasons we cannot offer these articles as downloads.

• Readability of Package Leaflets According to Age and Level of Education Thomas Paech, Birgit Ihnken, Dr. Klaus Menges and Dr. Thomas Dobmeyer
  Pharm. Ind. 73, Nr. 8, 1387-1398 (2011)

• Klinische Bewertung – Revision der MEDDEV 2.7.1 – Rev. 3
  Interpretationen aus der Praxis [Clinical evaluation Revision of MEDDEV 2.7.1 Rev. 3 Interpretations derived from actual practice]
  Dr. Tanja Babuke und Florian Tolkmitt
  Medizinprodukte Journal 17. Jahrgang · Heft 2 · 2010 S. 79-86

• Schöpke T. Botanik für Pharmazeuten. [Botany for pharmacists.]
  www.pharmakobotanik.de since 1997 (continuously extended)
  
  
• Handbuch Arzneimittelinformation. [Pharmaceutical information manual.] Anhalt E, Dobmeyer T, Fischer R, Gourdin C, Heyen P, Hoffmann R, Kasper E, Klüting A, Köhler S, Meister A.  Bundesverband der Arzneimittel-Hersteller e.V. (ed.); Schriftenreihe Qualitätssicherung, Bonn 2005
  
  
• Arzneimittelsicherheit in der Praxis. Leitfaden deutscher und internationaler Bestimmungen. [Drug safety in practice. Guide to German and international regulations.] Gourdin C, Heyen P, Wagner D, Dobmeyer T, Kroth E, Musilek M, Noe S, Schettler T. Bundesverband der Arzneimittel-Hersteller e.V. (ed.); Bonn 2006
  
  
• Firmeninternes Pharmakovigilanz-System im Rahmen des Antrages zur Arzneimittelzulassung / Vorschlag zur Erstellung einer Systembeschreibung. [The in-house pharmacovigilance system within the framework of the marketing authorisation application/Proposal for the formulation of a system description.] Borner M, Dobmeyer T, Dörre K, Düme U, Golly I, Gourdin C, Landsbeck E, Lerner-Hiller P, Kroth E, Naser B, Sobeck U, Weigl M. Pharm Ind. 68:1160-1166 (2006)
  
  
• Lidocaine 8 mg Sore Throat Lozenges in the Treatment of Acute Pharyngitis. Wonnemann M, Helm I, Stauss-Grabo M, Röttger-Luer P, Tran C-T, Canenbley R, Donath F, Nowak H, Schug BS, Blume HH. Arzneim.-Forsch. (Drug Research), 57(11): 689-697 (2007)
  
  
• Erstellung und Testung von Packungsbeilagen- Unter Berücksichtigung der Aspekte Patientenfreundlichkeit, medizinische Richtigkeit und rechtliche Vorgaben. [Creation and testing of package information leaflets taking into account patient friendliness, medical correctness and legal provisions.] Dobmeyer T, Beil C. Pharm Ind. 70:1316-1322 (2008)
  
  
• Lesbarkeitstests von Packungsbeilagen- Ergebnisse einer Untersuchung hinsichtlich der optimalen Gesaltung von Format und Schriftgröße. [Readability tests of package information leaflets – results of an investigation into optimum formats and font sizes.] Beil C, Menges K, Linz B, Dobmeyer T.  Pharm. Ind. 70:1323-1331 (2008)
  
  
• Regulatory Compliance as a Prerequisite for Lean Drug Development. Wellsow J. Hessen - Gateway to Contract Research in Europe - A Practical Guide to Sites and Services, Second Edition:14-16 (2009)
  
  
• Common Technical Document / Erfahrungen und Ausblicke fünf Jahre nach Implementierung. [Common Technical Document / Experience gained and future prospects five years after implementation.] Schröder C, Canenbley R, Pfaff, O. Pharm. Ind. 71(1):70-79 (2009)
  
  
• Evaluation of Bioequivalence of Drug Products. Position Statement of the International Association of Pharmaceutical Technology (APV e.V.) on the Draft Guideline on the Investigation of Bioequivalence by the CHMP, International Association for Pharmaceutical Technology (APV e. V.) incl. Zimmer M. Pharm. Ind. 71(2):258-262 (2009)
  
  
• Der Manager Regulatory Affairs. Schriftlicher Management-Lehrgang in 8 Lektionen. Lektion 3. Das Zulassungsdossier und seine Pflege. [The regulatory affairs manager. Written management training course in 8 stages. Stage 3. The marketing authorisation dossier and its maintenance.] Canenbley R. Euroforum Düsseldorf (2009)
  
  
• Das electronic Common Technical Document: Neue Anforderungen nicht nur für die Zulassung. [The electronic Common Technical Document: New requirements not only for
  marketing authorisation.] Canenbley R. DZKF: 74-78 (9/10-2009)pr