Ana Gonzalez Prada, Corporate Counsel E&C EMEA, Baxter Healthcare is currently presenting at Pharma Compliance 2013 on the topic of "Structuring and managing your legal and compliance teams internationally."
She begins by describing the different types of organisation models and the traditional areas of legal expertise required in pharma:
Types of Organisation Models
*traditional model- compliance and legal team combined
*hybrid- compliance and legal separated, but join forces at the top- one voice (Baxter model)
Traditional areas of legal expertise required in pharma
- regulatory law
- IP/IT law
- Data Protection
- International Trade
At what level should you build that expertise?
Gonzalez Prada argues against having it at a country level, mentioning the more segregation and separation, the more the ownership gets lost.Â She states it would be better to organise at a regional or global level.
Purpose- empower key stakeholders to do the right thing- tone at the top
meet regulators requirements
Strategy- shared compliance ownership and accountability through integration of compliance into commercial and functional operations
You don't want:
Your legal and compliance team to not communicate, not hold the same values, not carry across the same message, and not partner and work together.
Traditional elements of a compliance programme
Policies and Procedures/Communication & Training – need to have a global standard
Monitoring & Auditing/Investigations- need to have more independence
For more on compliance, join us today and tomorrow at the Royal Horseguards Hotel in London, UK.Â Contact Rachel Arthurson for last minute bookings on 44 20 7608 7045