Quality By Design: Integrated Risk Management During Late Stage Development

Visit WTG Corporate

• Why Attend
  • Why Attend
  • Frequently Asked Questions
  • Testimonials
• Course Leaders
• Attendees
• Partners
• Contact
• Course Schedule

Course Overview

Biopharmaceutical markets over the past 10 years have represented a large source of growth in the healthcare business, they will continue to do so and probably will represent together with Emerging Countries the most critical part of future growth for many Pharmaceutical companies. By nature, they are usually different: innovation in healthcare, creation of new markets, small number of competitors, variety of strategies that can be considered, private and public markets, the winner often takes most of the market, untraditional opportunities in Emerging Countries, etc.  Due to these specificities, speed and strategic foresight are all the more essential, as well as the need to be efficient at each stage of the game, with specific skills, methods and flexible implementation programs.

 The course aims to provide insight and to develop a flair for what may optimise Biopharmaceutical business. It reviews successful approaches to the three interrelated domains for Biopharmaceutical business achievement: planning/decision making, delivery of development conditions for success, delivery of launch success. Based on practical experience-derived methods, it will help participants improve or acquire new skills including how to best integrate existing functions, identify what resources are critical where and when thus supporting resource-sparing programs, optimise responsibility/accountability/governance systems, tackle key investments such as manufacturing and business development, optimise conditions for early commercial success.

The Course will Cover in Detail:

• Biopharmaceutical growth drivers
• How strategic decision making can optimise business prospects
• How to adapt methods, tools and governance to diverse projects and organisations
• Seeking enhanced achievement through business focus within an integrated development organisation
• Ø Skills, project management and organisational options
• Ø Functional activities (clinical, regulatory, manufacturing, business development, communication, etc.)
• Ø Alliances and partnerships
• Ø Pre-launch particularities
• Specifics linked to Emerging Markets
• Specifics linked to Public Markets
• The importance of early launch success
• The value of simplicity and good execution during launch

>> What will I be able to do after participating?

• Understand the critical success factors for a Biopharmaceutical / Vaccine business, the benefits of an integrated business focused development, and the factors which influence most launch achievements.
• Understand how to lead your functional responsibility into an integrated and efficient common effort.
• Propose and coordinate the implementation of business and outcome critical activities such as development check-points, alliances and partnerships, production strategy and capital investment, price/volume options, emerging world strategies.
• Lead, coordinate and optimise the output of critical functional activities during the development, pre-launch and launch phases of a Biopharmaceutical product.

>> Who is it for?

Experienced middle and senior management involved in the Biopharmaceutical and Vaccines industries or those who are called to collaborate with partners in this area. The functional roles which will benefit most from the course are those effectively involved in the 3 aspects of driving and delivering strategy: planning/decision making, development and delivery of pre-launch conditions for success, delivery of launch success. This includes functionally strategic planning groups often attached to the CEO office, heads of governance bodies, heads of project teams and functional heads engaged in successful development of the business project: clinical, regulatory, manufacturing, business development and marketing groups. The course will be equally relevant to executives in Pharmaceutical majors, biotechnology companies and start-up companies in line with the nature of Biopharmaceutical businesses and partnerships.