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 from a Trading Company wuth Q7 GMP focus
- Counterfeit Raw Materials: A Threat to the Safety of
Medicines
- Business of Counterfeit Heparin and its Implications
Excipients Session
- Results of the Public Consultation in Preparation of an
Excipients Directive
- EFCG Proposals for a Certification Scheme for Excipients
- The IPEC View and Guidance Documents on Excipients
Compliance
- The USP Approach to the Certification of Excipient
Manufacture
API Session
- EMEA’s Update on Activities Relating to Inspections and
Compliance of APIs
- 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
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Speakers
Speakers from authorities will include:
- Nicholas Buhay
FDA, USA
- Domenico DiGiorgio
AIFA, Italy
- François-Xavier Lery
EMEA, United Kingdom
- 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
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