Why regulatory strategy should be at the heart of your company strategy

Why regulatory strategy should be at the heart of your company strategy
£ 0.00

Small Biotech and Pharma companies are typically resource constrained and can understandably focus on commercial potential and clinical results. Regulatory Affairs and regulatory strategy in particular may not be considered a necessary core competence and something that can be readily be outsourced when the time comes. However, if appropriately crafted Regulatory strategy is the one place to align all strands of activity for a development asset and be fully in step with Company aspirations.

In this session we discuss why outsourcing your regulatory strategy may not be wise move. Here we propose that a smarter move would be to engage a Trusted Regulatory Adviser.

We will cover these areas:
  • Why your regulatory strategy should be integral to your company strategy
  • The benefits of a global approach to avoid development plan delays
  • Why you should outsource your Regulatory Strategy with caution
  • The significant value a Trusted Regulatory Adviser can bring.
Moderator
Steven French
Steven French is an accomplished business leader with more than 35 years’ experience in the Pharmaceutical Industry. He has significant experience of delivering large and complex programmes and has a sound and extensive regulatory affairs background gained in industry, management consulting and professional services.

Steven has worked in European and International Regulatory Affairs for Glaxo Laboratories, SmithKline Beecham Pharmaceuticals, Pfizer, GE Healthcare and Shionogi Pharmaceuticals. Here he has held regulatory strategy leadership roles as well as Global and European function leadership positions. He was Global Head of Regulatory Affairs for GE Healthcare and SVP of European Regulatory Affairs at Shionogi. He has extensive experience of Regulatory systems in European and International markets in particular China and the United States. He has worked across a range of therapeutic areas including anti-infectives, imaging, oncology and vaccines.

In addition to his regulatory experience in industry, Steven has extensive management consulting, regulatory consulting and professional services experience. He spent 5 years with PwC Consulting where he was Principal Consultant and Account Directory in their Pharmaceutical Industry practice, undertaking organisational reviews and assessments for several leading pharmaceutical organisations. He was also the Managing Director of NDA Regulatory in the UK, and Head of i3 Research Regulatory Affairs.

Throughout his career Steven has gained significant experience in strategy formulation, outsourcing management, business planning, process re-engineering, organizational improvement and performance management. He is an adept and pragmatic problem solver and a skilled programme leader.

Steven is Managing Director of SFPC Ltd, offering a range of organisational and strategic regulatory support to industry.
Benefits
Participants will be able to:
  • Share their own challenges with like-minded people
  • Pick up some successful approaches from others, to generating better collaboration and motivating a team
  • Hear some tips from our expert moderator
  • Elect to attend further sessions
Who we welcome
  • Senior leaders in small Biotech and Pharma organizations
  • - CEO
    - Head of Development
    - Head of Clinical Research/Chief Medical officer
    - Head of Regulatory Affairs
    - CFO
  • Pharmaceutical industry, biotech