professional development courses


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Biotechnology for the Non-Biotechnologists

This two-day Program will provide a basic understanding of the various elements of biotechnology drug development. You will learn the typical sequence of steps in the development process from discovery to approval, how to choose a CMO, the regulatory requirements for biotechnology drug development, an overview of mammalian cell manufacturing processes, and average costs for those items.

Turning 'Theory' into 'Practice'?

The Program will help executives to understand the timelines of drug development and why they are so long, ways to try to shorten those timelines such as Fast Track and Break Through Designation, the types of FDA meetings and when each is used. You will also learn about the legal responsibilities of executive management in the context of FDA, and the types of punitive actions FDA can enforce. The special requirements for biosimilars will be discussed, as will some of the differences in the requirements and expectations of FDA versus the EMA.

Who should attend?


Key areas to be covered in the programme and documentation

Day 1 - History of the FDA and drug regulation

History of Biologics

The Current Types of Processes

Plasmids - The epicenter of the IP

An Overview of Cell Lines

CMO Selection

Audits, MSAs, and Quality Agreements

An Overview of Mammalian Cell Processes

Fermentation - difference from mammalian cells


Day 2 - The Drug Development Process:

Nonclinical Studies

Clinical Studies

Developing the manufacturing process

What are you entitled to from the CMO?

Quality Assurance

Regulatory

Biosimilars - The Current Status

Additional Information

Consultants




Benefits to you

•Gain an introduction to the fundamental principles of biotechnology. •Understand the complexities in biotech manufacturing. •Improve your understanding of the key techniques used by biotechnologists. •Understand the key regulatory considerations for biopharmaceuticals. •Discuss advances in regulation – biosimilars and advanced therapies. •Learn how to identify potential patents, and why and how they must be protected.

Companies already benefiting include:

Pfizer Learning Center, Isis Pharmaceuticals Inc., Merck & Company Inc., Nerugen Corporation, Purdue Pharmaceuticals, Ranbaxy Pharmaceuticals Inc., Amgen Incorporated, Celegene Corporation, Forest Pharmaceuticals Inc.

Duration of Course

January 30 - 31, 2020 Day Course

Course details

Looking to train larger teams in this subject?

dzingim@marcusevansuk.comTailored in-house/in-company training courses and bespoke strategy workshops designed and delivered on-site throughout Europe according to your specific requirements.

All management, personal development and project management public courses featured in our Course Directory are also delivered on an In-Company basis.

Click Here for information on how this course can be delivered for you as an In-Company Training Solution

 


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Further information

UK Enquiries: +44 (0) 203 002 3057
or dzingim@marcusevansuk.com

Non-UK Enquiries: +420 (0)2 5570 7246
or training@marcusevanscz.com

North American Enquiries: +1 312 540 3000 X6714 or emilyj@marcusevansch.com

dzingim@marcusevansuk.com - Marketing Manager EMEA - Professional Training


Testimonials

"This course will allow my company to develop its existing strategies to a much greater and hopefully profitable level."

Managing Director, Tarmac