MARE BALTICUM LECTURES: Making a Medicine - Scientific, Regulatory and Ethical Considerations


Pharmaceutical Development - An Introduction to (Online) Resources

Date: 01./08./15.11.2019

Time: 11:15 a.m. - 12:00 p.m.

Lecturer: Dr. Anita Peil

Number of participants: Maximum of 25

Location: planned: IBIMA computer lab, 3rd floor, Children's Hospital

Language: English (German)

Target audience: Students in the life sciences, from B.Sc. level onwards

Participation fee: Free of charge

Course description: The pharmaceutical industry is one of the most publicized - and often criticized - components within the health-care sector. Prescription medicines have contributed major improvements to human health and will continue to do so. Regulations and regulatory authorities play key roles in assuring their quality, safety and efficacy. Still, while headlines often feature hope for new treatments arising in research (e.g., Alzheimer's disease), there are also sometimes reports of possible breaches of safety or ethics (consider opioids). How is it that these different aspects can arise within the same industry? Why does it take so long for a new drug to reach patients? Are regulations too strong or too weak? This overview is intended for anyone thinking about working in the pharmaceutical industry or elsewhere in the health-care sector where medicines play a role. The objective is to understand the guiding scientific principles of drug product development and how to find regulatory resources which allow an inside view on the processes involved in arriving at and managing a position on the market.  The lectures will be held in English, the language of the international pharmaceutical industry.  However, participants may ask questions and discuss in German. Participants are invited to submit topics or questions they would like to have addressed in advance of the lectures to the office of Prof. Georg Fuellen.

Pharmaceutical Development and Regulatory Issues

Date: 15.11.2019

Time: 3:00 p.m.

Lecturer: Dr. Anita Peil

Number of participants: Maximum of 10

Location: planned: IBIMA computer lab, 3rd floor, Children's Hospital

Language: English

Target audience: Doctoral candidates, postdocs, staff, PIs in the Life Sciences

Participation fee: Free of charge

Course description: In this seminar, focusing on the needs of the audience,   pharmaceutical development projects (planned or ongoing) will be advised from the industry perspective. General project management, exploration, validation and formulation issues, initiation of clinical trials, safety considerations, as well as regulatory issues will be considered towards maximizing success. Participants should submit questions or topics of interest 2 weeks in advance of the lecture.

 

Information about the lecturer

Key Expertise: Realization of new concepts, strategy formulation and implementation, international operations, multidisciplinary team management, staff development, crisis management

More information about Dr. Anita Peil

 

Registration

Deadline: 18 October 2019


Prof. Dr. Georg Fuellen
Director, Institute for Biostatistics and Informatics in Medicine and Ageing Research -- IBIMA
Rostock University Medical Center
http://www.ibima.med.uni-rostock.de/

fuellenuni-rostockde