| 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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| 2013 |
Dr. Christine Gescher (ehemals Kundinger) |
Development and regulatory strategy for a generic dry powder inhaler for submission in EU
as per the in-vitro only option in section 5.2 of OIP guideline (CPMP/EWP/4151/00 REV. 1) *** |
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| 2013 |
Silvia Gonzalez |
FDASIA "breakthrough" drug therapies – a real regulatory breakthrough for innovations? *** |
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| 2013 |
Gilda Gordon |
A critical review of the current marketing authorisation transfer procedure in Europe *** |
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