| 2019 |
Damian Kaminski |
The EU cosmetics regulation in comparison to medicinal products: Evaluation of a risk-based approach *** |
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| 2019 |
Dr. Eleni Karakasili |
Contained Use or Deliberate Release? - National regulatory requirements for clinical trials with gene therapy medicinal products containing or consisting of GMOs in Europe *** |
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| 2019 |
Franziska Köthe |
Reclassification of Insulin products from drugs under FDC Act to biologics under PHS Act after March 23, 2020 and its impact on product development related to CMC dossier contents also with regards to registration of "Follow-on" Insulins and comparison with other major markets |
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| 2019 |
Dr. Jens-Uwe Künstler |
Regulatory Considerations for Pre-filled Syringes in Clinical Development - an EU and US Perspective |
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| 2019 |
Dr. Sapuna Mary Kuriakose |
Opioid crisis in US - Describing the historical background and discussing the regulatory strategies to tackle the epidemic *** |
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| 2019 |
Zeineb Laghmani |
Referral under Article 31 of Directive 2001/83/EC: An example of vancomycin-containing medicinal products *** |
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| 2019 |
Dr. Tanja Lidy |
Drug shortages for supply-relevant medicinal products exemplified by vaccines - Notifications, reasons and effects *** |
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| 2019 |
Amelie Link |
Herausforderung Zusatznutzennachweis bei seltenen Treibermutationen - Nutzenbewertungsverfahren nach §35a SGB V zum NSCLC mit ALK- oder ROS1-Treibermutation (2012 bis 2018) *** |
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| 2019 |
Astrid Maeder-Jeske |
Antimicrobial Resistance - An analysis of the current situation with a special focus on policy approaches and regulations in the European Union, the United States and on the part of the WHO to prevent an escalation of the situation *** |
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| 2019 |
Xinyu Meng |
Medical Device Regulations in the People’s Republic of China - the New Trend and the Challenges and Opportunities to European Medical Device Manufacturers *** |
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| 2019 |
Dr. Melanie Mühlfelder |
Real-life experiences with approval of pediatric clinical trials in Germany |
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| 2019 |
Dr. Olga Nilmayer |
Regulatory requirements concerning the manufacture and clinical use of human cornea in Germany *** |
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| 2019 |
Stefanie Rodler |
Elemental Impurities in Drug Products: Challenges for the pharmaceutical industry in establishing limits based on ICH Q3D for alternative routes of administration *** |
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| 2019 |
Dr. Mareike Schnaars |
Regulatory Challenges and Strategies for Allergen Products in the European Union and Canada *** |
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| 2019 |
Caroline Schommer |
MDR's Article 117: Regulatory Strategy to Comply With the General Safety and Performance Requirements Set Out in Annex I in the Light of a Single Integral Drug Device Combination *** |
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| 2019 |
Carina Schunk |
Regulatory requirements related to the registration of generic orally inhaled drug products in the EU and US - A comparison of the European "stepwise approach" and US "weight of evidence approach" *** |
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| 2019 |
Dr. Karim Sempf |
The Valsartan Case and its Consequences for the Global Supply of Pharmaceutical Active Ingredients |
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| 2019 |
Theresa Sorgenfrei |
Readability and comprehensibility of package leaflets - recent efforts for improvement within the EU and a historical review *** |
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| 2019 |
Dr. Ansgar Stüken |
The New ICH Guideline ICH S5(R3) on Reproductive Toxicology on Medicinal Products for Human Use - Opportunities and Challenges for European Non-Clinical Drug Development *** |
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| 2019 |
Dr. Alexandra Thornagel |
Implikationen von Artikel 31-EU-Referrals in Deutschland am Beispiel von Metformin (EMEA/H/A-31/1432) und Valproat (EMEA/H/A-31/1454) *** |
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