| 2021 |
Johannes Korward |
Dry Eye Disease: Regulatory Requirements Differ Around the Globe – with Implications for Product Development and Patient Access. A review of standards for new ophthalmic therapies in key pharmaceutical markets. *** |
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| 2021 |
Dr. Karin Kroboth |
A Comparative Analysis of Antibody Drug Conjugates in Europe and the US |
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| 2021 |
Julia Leuthner |
PUMA-Arzneimittel in der Nutzenbewertung nach § 35a SGB V (2014-2019) |
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| 2021 |
Theresa Löschmann |
The Company Core Patient Information (CCPI) - a useful tool for regulatory compliance? |
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| 2021 |
Katarzyna Makosch |
Worksharing procedure - what’s the point? An overview about worksharing procedure as regulatory tool |
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| 2021 |
Dr. Sarah Matheisl |
Quality-related Challenges of Viral Vector-based Gene Therapy *** |
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| 2021 |
Marieke Ostwald (geb. Dölz) |
Herausforderungen eines pharmazeutischen Unternehmers durch verschiedene internationale Fälschungsschutz-Systeme *** |
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| 2021 |
Barbara Petzold |
Accelerated Development of COVID-19 Vaccines: Clinical Data Gaps Identified by Health Authorities and Respective Post-Authorisation Activities *** |
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| 2021 |
Anna Rubik |
Drug Shortage - A complex global challenge. Recent developments in the EU, industrial aspects with a special focus on Austria and an idea of international handling via a global portal *** |
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| 2021 |
Dr. Alex Savtschenko |
Preclinical toxicity profiles of authorised medicinal products: analysis and comparison between short-term and long-term repeated dose toxicity studies in animals *** |
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| 2021 |
Dr. Ramsi Siaj |
The New ICH-Guideline S11 on Nonclinical Safety Testing - Opportunities and Challenges for Overall Development of Paediatric Medicine *** |
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| 2021 |
Dr. David Thalmann |
New Dosage Forms of Old Substances - Regulatory Strategies and Challenges in the European Union *** |
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| 2021 |
Dr. Sara Tognarelli |
Between flexibility and standardization: the challenge of the first European Pharmacopoeia individual monograph for monoclonal antibodies. The case study of the monograph 2928 "Infliximab concentrated solution" |
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| 2021 |
Sandra Walkowiak |
Fast and Simplified Procedures for Herbal Medicinal Products in Pacific Alliance Countries |
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| 2021 |
Lucy Weinreich |
Der besondere Bedarf an nicht zugelassenen Arzneimitteln - Nationale Regelungen in Österreich und Deutschland mit Fokus auf den deutschen Einzelimport gem. § 73 Abs. 3 AMG *** |
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| 2020 |
Elizabeth Abari |
Decentralized trials - A survey of the regulatory and ethical environment when studies no longer take place in a traditional way |
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| 2020 |
Dr. Hamza Al-Tamari |
The European Commission's Proposed Regulation on Health Technology Assessment–Background, Challenges, and Opportunities *** |
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| 2020 |
Dr. Caroline Alba |
Import, Export, Storage and Distribution of Controlled Drugs - Regulations in UK, France, Germany *** |
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| 2020 |
Mohamed Amer |
Regulatory Affairs in Egypt |
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| 2020 |
Dr. Poonam Balani |
Regulatory requirements and actual data outcomes from EPARs on the Non-clinical Studies of ATMPs (Covering Gene Therapy, Somatic Cell Therapy), and Recombinant Proteins other than Monoclonal Antibodies based on Review of EPARs (12/2009-12/2019) *** |
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