- Next: on request
New EU GMP Annex 1 and its Impact on Pharmaceutical Manufacturers
Bespoke
High impact
This free webinar will explain the reasons for the revision of Annex 1 and will address the changes and implications for pharmaceutical manufacturers. Topics to be covered will include how to prepare your Contamination Control Strategy (CCS) document, and how to adapt to the principles of Quality Risk Management. The expectations of the regulatory authorities and the questions that may be encountered in audits/inspections will also be discussed.
- 1.5 CPD hours
-
Presented by Mustafa Edik
- Next: 19-20 Jul 2023 Live online
- Also: 21-24 Nov 2023 Live online
An Introduction to ISO 22716 - GMP for Cosmetic Products
Live online
Focused
This course will provide an essential overview of GMP in the production and manufacture of cosmetics. It will be particularly useful for Pharmaceutical and Biotech companies considering entering this market and it will also provide an opportunity for those who need to refresh their knowledge about the requirements.
- 12 CPD hours
-
Presented by Mustafa Edik
- Next: 12-13 Jul 2023 Live online
- Also: 30-31 Oct 2023 Live online
Biosimilars
Live online
Focused
A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.
- 12 CPD hours
-
Presented by Hans van Bruggen
-
and Marloes van der Geer
- Next: 26-30 Jun 2023 Live online
- Also: 27-29 Sep 2023 Classroom
- Also: 4-8 Dec 2023 Live online
Biotechnology for the Non-Biotechnologist
Live online, Classroom
Focused
An ideal course for non-scientists and scientists who need to understand the basic theory, principles, techniques and potential of biotechnology.
- 18 CPD hours
-
Presented by Mardon McFarlane
-
+ 7 more
- Next: 6-7 Jul 2023 Live online
- Also: 26-27 Oct 2023 Live online
Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products
Live online
Focused
The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.
- 12 CPD hours
-
Presented by Andrew Willis
- Next: 10 Oct 2023 Live online
Delivery of Biologics to the Nasal Cavity
Live online
Focused
The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.
- 3 CPD hours
-
Presented by Dr Irene Rossi
-
+ 3 more
- Next: 20 Oct 2023 Live online
US FDA - Understanding Key Factors When Working with the FDA
Live online
Focused
This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration). For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.
- 6 CPD hours
-
Presented by Andrew Willis