| 2016 |
Dr. Brita Schulze |
Different Salts of a Drug Substance - Comparison of Regulatory Pathways in the EU and USA *** |
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| 2016 |
Dr. Volker Spehr |
Virulence factor inhibition, a novel approach to treat life-threatening bacterial infections: Challenges for industry, legislation, and agencies *** |
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| 2016 |
Till Teschke |
Changes in the regulatory assessment of manufacturing process validation *** |
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| 2016 |
Anna Touhidi |
The Double Edged Regulation of Liquid Chemical Germicides Used in Healthcare Settings. The Burden of a Joint Jurisdiction, Demarcation of Categories and Regulatory Requirements in the United States of America *** |
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| 2016 |
Dr. Michael Türck |
Regulatory and Practical Consequences of the New Clinical Trial Regulation (EU) No 536/2014 for the Clinical Trial Application Processes of Pharmaceutical Companies and CROs *** |
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| 2016 |
Julia Vogel |
Assent - differences in Europe and potential for harmonization |
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| 2016 |
Cornelia Wagner |
Overview of the Active Substance Master File Approaches in the European Union, Japan, Brazil, Russia and the World Health Organization from the Perspective of an API Manufacturer of Small Molecules |
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| 2016 |
Svetlana Walter |
Dependencies between marketing authorisations in Developed and Emerging Markets – Implications for Regulatory Strategy *** |
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| 2016 |
Immanuel Weber |
New safety features against falsified medicines according to the Delegated Regulation (EU) 2016/161: Consequences for Parallel Distributors |
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| 2016 |
Dr. Ruth Zeller-Adam |
The European Council's Partial General Approach to the Proposal for a Medical Device Regulation: Its potential implications on demarcation, classification, and conformity assessment of substance-based medical devices *** |
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| 2016 |
Dr. Valeria Ziemann |
Overview of Regulatory Requirements for Marketing Authorisations of Pharmaceutical Products in Countries of Eurasian Economic Union |
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| 2016 |
Astrid Zimmermann |
Regulatory Requirements of Marketing Authorization Holder Transfers in International Markets |
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| 2016 |
Dr. Ina Zschocke |
Standard for Outcome Measures in Clinical Trials for the treatment of plaque psoriasis supporting Labelling Claim and their application in practice – a critical review of the EMA Guideline CHMP/EWP/2454/02corr and a proposal for future development *** |
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| 2015 |
Dr. Andrea Abele |
Skinny labelling *** |
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| 2015 |
Pablo Gabriel Amaya Rodriguez |
Pharmaceutical pricing and reimbursement in Latin America - Implications for Regulatory Strategy *** |
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| 2015 |
Dr. Jennifer Anthöfer |
Drug Development and Critical Analysis of the Reliability of Preclinical Studies *** |
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| 2015 |
Dr. Kerstin Bade |
The revision of European Directives on medical devices 90/385/EWG (AIMDD) and 93/42/EWG (MDD): Present requirements concerning clinical investigation and clinical evaluation in comparison to Commission`s proposal for a new Regulation on medical devices and those discussed by the EU Parliament and the Council in the course of the legislation procedure |
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| 2015 |
Cora Bergmann |
Sunset Clause in Germany – Provisions for nationally authorised human medicinal products under the responsibility of the Federal Institut for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) |
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| 2015 |
Bettina Bickel |
Heparin - Changes in regulatory requirements and consequences thereof *** |
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| 2015 |
Olga Borsuk |
The repurposing of already marketing drugs to be used in the field of rare diseases: challenges, advantages and regulatory strategy in the European Union |
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