Biologics Development

The presentations below are from a training course on biotech development called "Regulatory Affairs for Biotech:  Critical Steps for Compliance."

 

The presentations below are from other seminars.

 

Controlled Substances

The presentations below are from a training course on controlled substances compliance that ran from 1999 through 2005.  So, some of the regulatory references are dated but the overall concepts are still applicable.

 

Biosimilars & Comparability (published articles)

Key Articles

Provided below are links to some of my published articles and presentations on biosimilars.

 

Biosimilars & Comparability (presentations)

40th Annual Drug Information Association (DIA) Meeting:  Session on Regulatory and Development Considerations for Multisource Biotech (June 2004)

IIR International Generics Strategy:  Pre-Conference Symposium on Comparable Biotech Products (May 22, 2002)(Barcelona, Spain)

Management Forum:  Comparability Issues in the Development of Biotechnology Products and Consideration of Biotech Generics (Oct 25, 2002) (London, UK)

1st European Generic Association (EGA) Symposium on 'Biotech Generics' (May 23, 2003) (London, UK)

EMEA/DIA Joint Workshop:  EMEA New Guidelines for Development & Approval of Biosimilars (Dec 2005) (Paris, France)

 

Templates Central

project management & planning

Provided below are templates for project planning of various types of regulatory submissions.  They are in Word or Project format to allow editing and customizing for your projects.

 

Audit checklists

Provided below are audit checklists for various types of facilities and operations.  As with the documents above, they are in Word format to allow editing and customizing for your projects.