TBC Seminars

11:30 am - 11:50 am

Sustainability in Pharmaceuticals – Learning From Other Industries

As the challenge to support an increasing population becomes more and more evident across the globe, sustainability is increasingly important. One of the most important tasks of our time is to produce high-quality and safe products while saving resources and ensuring quality of life. We (BASF) play an important role in solving these tasks. And our industry is capable of and has the responsibility to make a relevant contribution.

This presentation will discuss sustainability in the context of the chemical industry and look at how this may be applicable to pharmaceutical manufacture.

12:10 pm - 12:30 pm

The Quality Management System

12:30 pm - 12:50 pm

From Batch to Continuous – New Opportunities for Supercritical CO2 Technology in (Bio)pharmaceutical Manufacturing

This presentation will provide an overview on existing methods for the production of pharmaceutical nanoparticles and show case studies on the production and control of the solid state form of APIs (e.g. polymorphs, cocrystals) using batch and continuous supercritical methods. A particular focus will be provided on a novel technology that uses nano spray drying as part of a continuous process for the production, isolation and downstream processing of nanoparticles. Examples will be provided on API nanomaterials produced which feature optimal rheological properties typical of large micron-sized particles, while still maintaining high dissolution rate profiles typical of nano-sized particles.

Speaker

  • View full profile for Dr Luis PadrelaDr Luis Padrela Lecturer/Principle Investigator - SSPC, Bernal Institute, University of Limerick
9:55 am - 10:15 am

QbD is not Just DoE

Speaker

2:00 pm - 2:20 pm

Vitamin D: a Clinical Science Update on the Efficacy of High Dose treatment

Vitamin D is perhaps more correctly thought of as a hormone. It remains an extremely popular subject of clinical trials globally. However, governmental intake recommendations are based on the avoidance of severe deficiency and the onset of symptoms such as rickets. They also often fail to take into account the exposure of the skin of their populations to sunlight throughout the year. To have a benefit in many pathologies, much higher doses of Vitamin D are required. This paper will review the current use of adjunctive therapies untilising high dose Vitamin D.

2:20 pm - 2:40 pm

Presentation Skills

2:40 pm - 3:00 pm

GMP Obligations for the Marketing Authorisation Holder

The pharmaceutical manufacturing sector is increasingly working to an outsourced model where the MA Holder is a virtual (office based) entity, without any traditional manufacturing or testing activities on site.
This leads to the false assumption that GMP/GDP do not apply to the MA Holder facility (of course they do).
The EMA have published a reflection paper on GMP for Marketing Authorisation Holders; here are some practical steps an MAH can take to ensure compliance without overloading current systems.

2:40 pm - 3:00 pm

Implementation of Clinical Trials Regulation