| 2017 |
Dr. Dimitrios Mintsioglou |
Quality Management in clinical trials: Comparison of the requirements stated in the Integrated Addendum to ICH E6(R1) Guideline for Good Clinical Practice E6(R2) for medicinal products and the ISO 14155:2011 for medical devices *** |
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| 2017 |
Dr. Tobias Morawe |
Moving into future - a pure electronic package leaflet as a chance for patients, the pharmaceutical industry and health authorities |
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| 2017 |
Dr. Barbara Oberwallner |
Implementation of authority requirements or recommendations into the package leaflet – a comparative study in three European countries *** |
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| 2017 |
Dr. Elza Okon |
Marketing authorization process and regulation of veterinary medicinal products in the CIS countries *** |
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| 2017 |
Sabine Prohl |
Background, evaluation, and impact of the new EMA-guideline: "Guideline on setting health base exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" *** |
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| 2017 |
Anna Reifschneider |
The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices *** |
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| 2017 |
Julia Richnow |
Benefit-Risk Assessment of Human Medicines - A Comparison of EMA’s and FDA’s Approach *** |
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| 2017 |
Dr. Georgeta-Irina Sava-Piroddi |
Biomarkers in oncological drug development: the potential and the challenges leading the way towards personalized medicine |
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| 2017 |
Dr. Gritt Schäfer |
Biotechnology: Regulatory Requirements On Continuous Manufacturing for (glycosylated) Monoclonal Antibodies *** |
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| 2017 |
Ute Scheibel |
Regulatory considerations in cooperation of small and medium-sized enterprises with their foreign business partners regarding marketing authorisation applications for herbal medicinal products *** |
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| 2017 |
Dominik Sebastian |
Clinical Evidence Under the New Regulation 2017/746/EU on In Vitro Diagnostic Medical Devices |
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| 2017 |
Dr. Eva Skerhutt |
Making an old biologic great again - a regulatory survey about new indications for an old product and their requirements |
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| 2017 |
Doreen Stoof |
The Republic of Serbia on its way into the European Union? Review of regulatory preparation, discussion of challenges and future prospects for registration procedures of medicinal products |
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| 2017 |
Dr. Christian Strube |
Challenges and Considerations in Developing a Regulatory Compliance Department in a Medium-sized German Pharmaceutical Company *** |
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| 2017 |
Dr. Nadine Temme |
Delivery of nucleic acids mediated by engineered protein nanoparticles - Preclinical development from a regulatory point of view |
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| 2017 |
Dr. Christina Wallkötter |
Referral procedures of Directive 2001/82/EC - General principles, analysis of Article 78 procedures and future outlook |
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| 2017 |
Anna Wehage |
Brexit: Possible regulatory impacts on the pharmaceutical industry and marketing authorisation holders in Europe *** |
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| 2017 |
Birte Weselmann |
International cooperation among Drug Regulatory Authorities |
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| 2017 |
Anja Wiechmann |
Post-Approval Change Management Systems in the ICH Region with Focus on "Established Conditions" *** |
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| 2017 |
Barbara Wiglinghoff |
Medication errors - new challenges for pharmaceutical industry, authorities and health care professionals including the guides "EMA/762563/2014" and "EMA/606103/2014" and selected drug therapy safety projects *** |
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