MSc Thesis List

Year Master thesis themes

2012

Regulatory aspects of process development and validation for biological substances: From traditional to enhanced approach (Confidential)

2013

Harmonisation of Health Economic Assessments and biosimilars impact on value

2013

Novartis experience with Joint Scientific Advice

2013

Monoclonal antibodies for pediatrics in the European Union

2013

Companion diagnostics: Present European regulatory framework and upcoming challenges

2014

Health Technology Assessment requirements and the implications on global development of biopharmaceuticals

2014

A Roadmap toward Clinical Translation of Genetically-Modified Stem Cells for Treatment of HIV

2015

Current regulatory requirements for bioequivalence studies in the EU and their impact on generic drug development projects by reference to an example from a pharmaceutical company (Confidential)

2015

Batch release of influenza vaccines within the European OCABR Network in Germany: Is it still useful?

2015

The evolving clinical research environment in MENA region: Jordan as a case study

2015

Unwanted Immunogenicity -the legal basis in the European Union

2015 Control of medicines: to what extent have OMCLs had a positive impact on the quality of biological medicinal products?
2015 Biosimilars: Navigating a Global Development through a Diverse Regulatory Landscape
2015 Classification and Similarity Assessment of Advanced Therapy Medicinal Products in the European Union
2015

"Parallel Protocol Assistance” with EMA and HTA bodies for AIN457 in the treatment of non-infectious uveitis (Confidential)

2015

Development of regulatory system in Russia and Ukraine with the focus on biosimilars

2015

Clearing the haze: A study of the trends of withdrawals of medicinal products in the EU, and the potential impact of the pharmacovigilance legislations

2015

Quality Aspects of Antibody-Drug Conjugates

2015

Comparison of Quality-­by-­Design Implementation between Biological and Chemical Medicinal Products

2016

Quality Aspects of Antibody-Drug Conjugates

2016

Comparison of Quality-by- Design Implementation between Biological and Chemical Medicinal Products

2016

Priority Review and Orphan Drug Regulation in Emering Markets

2016

Translation of the Mutual Recognition procedure from European Union to African countries Role Model Riamet/Coartam

2016

Medicinal products registered under the centralized procedure undergoing additional monitoring

2016

Clinical Data Transparency Strategy of the Industry in Response to EMA Policy 0070 and Clinical Trial Regulation Requirements

2016 Status of hospital exemption in the EU and the path forward
2016 The evaluation of non-clinical requirements for biosimilars
2016

Global regulatory strategy regarding Marketing Authorization, taking into account the emerging markets

2016

Regulatory comparison and analysis of orphan medicinal products in the US and the EU

2016

Unintended Immunogenicity of Biopharmaceutical products: the value of an integrated Inter- and Multidisciplinary risk- based approach

2016

Regulatory Practice for Handling Type IB Grouped Variations via Worksharing Procedure under Mutual Recognition and Decentralised Procedure

2016

A Roadmap for addressing CMC and Nonclinical Regulatory Challenges for Induced Pluripotent Stem Cell-derived Therapeutic Medicinal Products

2016

Paediatric Post Authorisation Measure P46 in the European Union and ist impact on the label based on a real life example of an anti-infective drug

2016

Cell and Virus Banking Concepts in the Production of Biologic Medicinal Products: Regulatory and Quality Aspects in the European Legislation and Impact on the Biopharmaceutic Practice

2016

10 years of independent marketing authorisations by Swissmedic: A comparison between Swissmedic, the European Medicines Agency and the U.S. Food and Drug Administration

2016 Evaluation of the Suitability of a Post-Approval Change
2016 Management Protocol for late CMC Development
2016

Accelerated regulatory pathways in US and EU: The success story of the FDA breakthrough therapy designation with focus on oncology drugs and prospects regarding an equivalent in the EU

2016

The foundation of biosimilar development - focus on biotechnology derived biosimilar products

2016

Immuno-Oncology /I-O- gene therapies, cell therapies and other immunotherapies such as check point inhibitors: understanding the shifting landscape in cancer research and treatment to enhance the regulatory approach excellence and to improve patient's access

2016 Drug labeling for Pregnancy and Breastfeeding
2016

Regulation of in vitro companion diagnostic device in the USA and EU