Basel, 29-31 Oct 2019

3 day Masterclass



Understanding Biosimilars in a complex regulatory and market environment

This course extrapolates from conventional generics into the specialised area of biosimilars. By combining aspects of technology, regulatory affairs and commercial aspects, this course will provide you with a wide ranging overview of the status of the biosimilar industry.

Learn bulb

get the latest insight

Gain a firm understanding of the CMC, Nonclinical & Clinical regulatory requirements and expectations (FDA, EMA and WHO) for biosimilars

Learn bulb

expand your knowledge

Appreciate why biosimilars are not treated by the regulatory authorities as bio-generics

Learn bulb

get practical

Partake in a comprehensive, scientific biosimilarity exercise to understand what has worked and what has not, when bringing biosimilars to the market


Biosimilars are very much more complicated than small molecules in terms of manufacturing and testing and this leads to a level of uncertainty that results in additional requirements in terms of regulatory approvals. 

Registration processes for these products are completely different in the European Union and the USA, and price rebates are hugely different. Almost daily there are new requirements related to such simple things as how the biosimlar should be named and whether such products are substitutable or not. These changes dramatically affect the strategy companies need to adopt and this course will show how these changes relate to market situations and forward planning.


book today

In just 3 days you will:

  • Understand the difference between biologic drugs and small molecules
  • Look at some of the manufacturing constraints in terms of Biosimilar processing
  • See how these constraint affect regulatory approval processes and market impact
  • Review the main Bisimilar approvals and the companies working in the Biosimilar space
  • Get insights into the areas of dispute including nomenclature, substitution, interchangeability and extrapolation
  • Discover how these areas can have a dramatic effect on market models
  • Consider the life cycle defence mechanisms of the innovator biologics including scientific approaches and legal and intellectual property issues

Meet your instructor

Malcolm Ross has over 30 years' experience in the pharmaceutical industry, the last 20 being at corporate level. Malcolm is a qualified pharmacist with a PhD in medicinal chemistry. He has specialised in product development, quality and regulatory affairs and has held senior positions with a number of companies including Teva, Taro, Par and Polpharma as well as being CEO of a CRO

Since establishing himself as an independent consultant in Basel, Switzerland in 2006 he has worked with innovative Pharma as a technical expert and in Quality assurance of clinical supplies.

He has consulted for a number ofpharmaceutical companies both innovator and generic on technical subjects and on quality matters. He has run professional workshops in the US, Indian, China and throughout Europe. He also advises on strategy and strategic planning.

Organisations that will benefit:

  • Biotechnology Companies
  • Innovative Pharma Companies
  • Generic Pharma Companies
  • Investors & Banks
  • Private Equity & Hedge Funds
  • Law Firms
  • Suppliers

Who will attend:

  • C-Level Executives
  • Biosimilars
  • R&D
  • Product Safety & Quality Management
  • Manufacturing Personnel
  • Project Managers
  • Product Development
  • Strategy Planning
  • Regulatory/Legal Affairs & Compliance
  • Business Development & Sales

Course Agenda

  • The Big Picture
  • Speed Networking
  • Overview of Biologics
  • Market Considerations
  • What are the main Biosimilars
  • Commercial Aspects
  • Who are the Biosimilars Players?
  • Biosimilar Nomenclature
  • Substitution, Interchangeability and Extrapolation
  • Regulatory Pathways for the approval of biosimilars
  • Life Cycle Management and Innovator Defence Mechanisms
  • What Does The Future Hold?
  • WRAP

For further information please call: +44 (0)207 092 1045

  • “The depth and knowledge of my trainer was extremely impressive. In 3 days I have had, without a doubt, a masterclass on the industry. Truly world class.”

    - Gordon Dowall Potter, Past Delegate

  • “Well worth 3 days of study!”

    - Syed Hamza, Past Delegate

  • “The training was excellent! I give it a 10 and will get my trainer's support for my next challenges.”

    - Head of Partnerships & Customer Loyalty at Avis Budget, Past Delegate

  • “Extremely constructive course with a very good dynamic and passionate trainer.”

    - Managing Director at BNP Paribas, Past Delegate

  • “Impressive and cooperative trainer who wanted to make sure the delegates understood.”

    - Budgeting, Planning & Reporting Manager, Past Delegate


We can come to you too! If you have a team of six or more, why not hold a private course? Our experts come to you and the course is tailored to your requirements.

Call +44 (0)20 7092 1045 (United Kingdom)
or (Asia Pacific)
for more details


Sign up for our Monthly Course Calendars