The Clinical Development team develops new therapeutic strategies for the treatment of diseases, especially in indications with a high medical need. The experts of this team understand the importance of clinical investigations for the successful introduction and acceptance of new therapies. They manage and monitor all medical aspects of MorphoSys’s compounds in clinical trials, including the development of study protocols and reports. They also assess the potential development of an area of research.
Clinical development expertise
The department for Drug Safety and Pharmacovigilance is responsible for the collection, detection, assessment, monitoring and prevention of adverse events in clinical trials which are sponsored by MorphoSys. Adverse events are unwanted effects which may be caused by taking a drug. Drug-related side effects can be mild, such as a stomach ache or drowsiness, and go away after you stop taking the drug. Others can be more serious or even life-threatening. Through a concise and rapid exchange of safety information among all parties, our safety and surveillance experts identify potential hazards associated with pharmaceutical products and minimize the risk for patients when taking part in a clinical trial.
Our Regulatory Affairs team is a strategic, solution oriented and collaborative business partner for drug development and commercialisation of MorphoSys’s proprietary development programs.
The team is responsible for designing and implementing global regulatory strategies to achieve company’s goals in accordance with increasingly complex regulatory requirements and with the highest level of compliance. We monitor and help the Company to navigate the regulatory environment, drive submission processes (clinical trials and Marketing Authorizations) and lead interactions with Health Authorities with the aim to expedite and maintain patients ‘access to innovative therapies. We also support Due Diligences and in-licensing projects.
The Quality Assurance department is responsible for the implementation, oversight and continuous improvement of a quality management system covering relevant aspects of good clinical practice (GCP), good manufacturing practice (GMP) and good laboratory practice (GLP). Quality Assurance provides advice and support for the quality management system that is in place, ensuring compliance with applicable laws, regulations and guidelines as well as a constant high quality for the whole development process.