The right approach to all the CMC (Chemical, Manufacturing and Controls) aspects is key for the development and approval of new drugs. Taking the wrong decisions in areas such as formulation development, process development or analytics development may result in rejected batches, CMC deficiencies issued by Regulatory Agencies, stability issues, etc. that will significantly delay the clinical trials. These delays may have an impact in our societies, as the treatments cannot reach the patients on-time, but also a significant budget increase that may even cancel the project.
At this webinar, we will go deeply into some key development matters that will allow you to have a clear picture of your CMC needs in your path to the clinic.
Firstly, we will recommend you the appropriate effort level required at all clinical phases in terms of regulatory compliance. Analytics requirements, validation needs, justification of specifications, etc. will be clarified according to our long experience.
Secondly, different alternatives will be proposed for the formulation and process development with a clear focus on oral solid drugs and more specifically, low solubility molecules.
Thirdly, a process map for reaching the clinic in the shortest time will be shown to the audience.
CMC aspects are of paramount importance for pharmaceutical companies that are developing new drugs, no matter the company size or intended clinical application. At this webinar, we will provide you relevant tips for dealing correctly with the regulatory requirements, the formulation or process development strategy and a whole process view that will allow you to avoid some bumps in your road to the clinical study.
Key Learning Objectives
- Understand the regulatory requirements related to the CMC area during the clinical phases.
- Learn efficient formulation development approaches for oral dosage forms.
- Discover a clear view of the development and manufacture of clinical trial materials.
