Your Expert Trainer
- More than 35 years of drug development experience in over 15 therapeutic areas in the EU and North American pharmaceutical industry, 25 years of which have been in regulatory affairs. - His e..
Leading Practical & Case-study Driven BIOSIMILARS MASTERCLASS FOCUSED ON 3 MAJOR ASPECTS – TECHNICAL, COMMERCIAL AND REGULATORY!
This 3-Day Comprehensive Biosimilars Masterclass has been designed to provide you with a complete guide to the technical, regulatory and commercial aspects of biosimilars. It will go in-depth to cover all the necessary knowledge, principles and lessons learned on Biosimilars through case studies, project activities and practical workshops.
Key areas of focus include insights into EMA and FDA Biosimilars, new biologics development, regulatory framework and considerations for Biosmilars, market access and product development strategies for Biosimilars, success factors in Biosimilars manufacturing and approval processes, Biosimilars market trends in EU, USA and key rest of the world countries, Biosimilars penetration, technical & commercial aspects of biosimilars amongst others.
As with all Equip Global Courses, the emphasis is very much on the practical and interactive exercises and real-life case studies. In addition to presentations of the subjects, participants will be challenged in actual project case studies to apply the principles discussed. It will also encourage the attendees to develop the tools to implement change upon returning to their work place.
If you are looking for an in-depth and practical Biosimilars masterclass, this is the one!
This Masterclass is suitable for the following professionals including:
Senior Executives, Managers, Directors, VPs, interested planning or actively working on biosimilars, also, and/or biologics/biotech medicines industries from:
- Business development
- Marketing and Sales
- Drug development
- Regulatory affairs EMA, FDA and international
- Chemistry, manufacturing and control, development QC & QA
- Quality and pharmaceutical development
- Clinical development/Medical Affairs
- Nonclinical development
5 KEY TAKEAWAYS OF ATTENDING THIS MASTERCLASS:
Unlike other trainings, this masterclass focus on PRACTICALITY, CASE STUDIES & GROUP EXCERSISES - Participate in several mini-workshops and group activities focusing on different types of biosimilars developments and programs!
Learn in-detail the technical and manufacturing aspects of Biosimilars and how you can overcome some of the biggest challenges
Gain regulatory intelligence and see how you can accelerate regulatory approval process whilst complying to regulations
Find out more about market models, pricing strategies and commercial best practices for Biosimilars
- Understand in detail key topic areas including nomenclature, substitution, interchangeability, extrapolation, immunogenicity management and orphan drug development!
Like to receive the agenda of the masterclass? Email us today at email@example.com for more information!