| 2014 |
Jing Yuan |
Comparison of Medical Devices Regulations in the EU and the People's Republic of China-Current situation and possible implications of the new Chinese Medical Device Guideline (2014) |
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| 2014 |
Dr. Yuan Zhao |
The regulatory process of electronic submission and its optimization |
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| 2013 |
Dr. Heidrun Albrecht |
Experiences with PIPs and their required revisions on the critical path of the development of medicines in indications for adult patients |
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| 2013 |
Dr. Martina Arnold |
Better Medicines for Older People - The EMA Geriatric Medicines Strategy |
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| 2013 |
Dr. Fatima Bicane |
Abuse Deterrent Formulation: The new approach to reduce prescription drug abuse in the United States |
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| 2013 |
Jochen Bierlein |
Specific requirements of the new Pharmacovigilance legislation on the development and compilation of a dossier for a generic medicinal product (new application and life cycle management acitivities) |
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| 2013 |
Guido Bockler |
The new Directive 2010/63/EU and its implementation in the European Economic Area (EEA): an Overview |
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| 2013 |
Clelia Bonadei |
Obligations of economic operators, traceability, vigilance and market surveillance of medical devices as foreseen by the EU Commission Proposal for a Regulation on Medical Devices of 26 Sept. 2012: comparison with existing requirements and evaluation |
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| 2013 |
Dr. Carmen Boxler |
"Compassionate Use", its practical implications and comparison of the regulatory framework of France, Spain, Germany and the United Kingdom |
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| 2013 |
Dr. Annika Brendle |
Mechanisms of carcinogenesis and their role in anti-cancer drug approvals via the EU centralised procedure (1995–2009) |
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| 2013 |
Dr. Christoph Brenner |
Submission-relevant Illustration of Risk Management in Pharmaceutical Development |
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| 2013 |
Dr. Sarah Burrack |
Status, challenges and regulatory strategies to develop a malaria vaccine |
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| 2013 |
Claudia Callies-Klüpfel |
The new European Health Claims Regulation establishing a List of permitted Health Claims: Questions around its Application and the current State of Discussion to the “Claims on Hold” and to the “Botanicals” as well as a comparative |
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| 2013 |
Esther Cónsul Tejero |
Melde- und Bobachtungssystem für Medizinprodukte - eine statistische Auswertung anhand eines Beispiels |
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| 2013 |
Alex Dranov |
European View on Current Regulatory Legislation in the CIS Countries. Marketing Authorisation of Herbal Medicinal Products in Russia and the Ukraine |
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| 2013 |
Inga Kristin Drosse |
Antibiotics in veterinary medicine - A European Regulatory Perspective |
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| 2013 |
Berit Fasse |
Acceptability of brand names for human medicinal products. With focus on German non-generic OTC umbrella brand discussion |
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| 2013 |
Dr. Thomas Flötotto |
Classification of Antiseptics and Disinfectants for Human use. The Demarcation between Biocides, Medicinal Products, Medical Devices and Cosmetics |
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| 2013 |
Karsten Gavenis |
Conducting Clinical Trials in Orthopedic Indications in Germany |
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| 2013 |
Mecit Gedik |
Verbesserung der Arzneimittelsicherheit durch Aufnahme in das BtM-Gesetz am Beispiel des Tilidins |
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