03 - 04 September, 2020 | The Westin Grand Munich, Munich, Germany
Luba Skibo
Principal Consultant
Skibo Regulatory Consulting
Check out the incredible speaker line-up to see who will be joining Luba.
Download The Latest AgendaConference Day Two
Friday, September 4th, 2020
4:20 PM Emerging Markets and the Impact on CMO/Sponsor Relationships - Russia and EAEU Case Study
• Get to grips with the regulatory basis for Russian HA site inspections and how to implement a risk based approach to resolve the situation
• Determine the impact on CMO manufacturing when GMP status isn’t granted
• Review the changes to expect from the EAEU GMP regulation being adopted and how to prepare
• Whose responsibility is this – the site or the sponsor?