Programme
General Session: Market Situation and Legal Aspects
- Today’s Pharma Raw Material Market for APIs and Excipients
- Insurance and Legal Aspects of Pharma Raw Material Sourcing
- Traded Pharma Raw Materials – Compliance and EU Market
Situation: View from a Trading Company with Q7 GMP focus
- Traded Pharma Raw Materials – Compliance and EU Market
Situation: Views on how to improve the overall compliance
situation for APIs imported from China
- Counterfeit Raw Materials: A threat to the safety of
medicines
Excipients Session
- Status of the European Commission’s work on designing
GMP-based Excipient Regulations
- EFCG Proposals for a Certification Scheme for Excipients
- The IPEC View and Guidance Documents on Excipients’
compliance
API Session
- EMEA’s Update on activities relating to inspections and
compliance of APIs
- Heads of Medicines Agencies’ API Strategy
- FDA’s New API Strategy to better protect US Consumers
- API GMP and Good Distribution Practice Inspections findings
- New API regulations and other API developments in China –
State of Play
|
Speakers
Speakers from authorities will include:
- Nicholas Buhay
FDA, USA
- David Cockburn
EMEA, United Kingdom
- Domenico DiGiorgio
AIFA, Italy
- John Taylor
MHRA, United Kingdom
- Lionel Viornery
AFSSAPS, France
Speakers from industry will include:
- Tim Bölke
BASF, Germany
- Arnulf Heubner
Merck KGaA, Germany
- Charles Hu
BimSifram Group, France
- Erol Thomas Isim
Pharma Action, Germany
- Carsten Krüger
Forstmann Kleist & Partner, Germany
- Iain Moore
IPEC Europe, Croda, UK
- Guy Villax
Hovione, Portugal
|
