Webinar

WEBINAR

Managing Global Submissions with Lean Regulatory Teams

Speaker:James Rawls , Qansy Salako

RAPS and MakroCare are holding a webcast on “Managing Global Submissions with Lean Regulatory Teams”.

The key to effective and efficient R&D is the ability to commercialize new products quickly and effectively. With rising competition, pharmaceutical and device companies worldwide have gone beyond the boundaries and placed many new products in global markets to gain market share and increase earnings. Now, the challenge is to obtain timely marketing approval and maintain those licenses.

Navigating global markets constantly poses many unexpected questions. It is important for the regulatory team to be knowledgeable about the trends, the constant regulatory changes and stringent regulatory requirements of regulators in these countries. Given the challenges, regulatory teams should be competent enough and well trained, since a small delay in getting marketing approval can mean a huge loss in terms of market share.

This webcast will focus on a five-point strategy that regulatory leaders should consider when they start the journey toward a lean team.

• Develop a platform for change
• Trim the fat
• Develop a specific plan for improvement
• Implement changes
• Measure, monitor and sustain

LEARNING OBJECTIVES

Upon completion of this webcast, participants should

• Understand regulatory strategies in managing global challenges for submissions with lean regulatory teams
• Understand regulatory information management requirements for all the stake holders involved in the regulatory process