1. IPEC Overview The Impact of Globalisation and IPEC’s Role Janeen Skutnik Past Chair – IPEC Americas

2. IPEC Mission Non-profit Association Represent: Excipient Suppliers, Distributors & Pharmaceutical Manufacturers Collaborate with our partner regional IPEC groups to: –Develop, implement, and promote voluntary guidance for excipients –Encourage adoption of scientifically appropriate regulatory and compendial standards –Assist, educate, and cooperate to advance public health

3. IPEC Organisation Several Regional/National Organisations –IPEC Americas –IPEC Europe –IPEC Japan –IPEC China (2008) –Brasil (Partnership with SindusFarma) –IPEC India (Forming)

4. IPEC Priorities Supply Chain –Monitoring the Geo-political environment for potential vulnerabilities –Excipient GMPs & GDPs –Excipient Auditing & Auditor Training –Quality Agreements –Excipient Qualification –EIP –Excipient Pedigree –IPEC Guidelines –Looking for new partnerships

5. IPEC FEDERATION

6. IPEC Federation: What is it? Concept was born in 2009 –Evolved from TriPEC Concept –Formalize interactions –Provide a mechanism for developing consensus based positions across regions –Set priorities for issues that interest/affect globally Development –IPEC Americas; IPEC Europe, IPEC Japan and IPEC China Set up in Belgium

7. IPEC Federation Objective: promoting the quality, safety and functionality of pharmaceutical and related healthcare products worldwide. Full Members –Original PECs + IPEC China Associate Members –Category added for new PECs that may be created –Allows time for them to familiarise themselves with IPEC priorities, mission and vision and translate guidances

8. Excipients Excipients ≠ Inert Excipients –Are added to aid in manufacturability, quality and/or performance of the finished product –Enable API to be converted to medicinal product that can be administered safely and efficaciously to the patient.

9. Globalisation: Impact on Excipients Global companies need global excipients –A rarity, due to differing regulations, legislation, guidance IPEC Provides Solutions –Engagement of regulators and governments –Brining together global industry Excipient makers, users, distributors –Development of white papers and guidances

10. The Impact of Globalisation Industry functions globally –Global sourcing –Global Supply Chains Systems & processes haven’t adapted to accommodate globalisation

11. The Impact of Globalisation Need for Increased Transparency –Pharmaceutical manufacturers, excipient suppliers, distributors and other actors throughout the lifecycle and supply chain must communicate with each other –Global regulators and governments need to partner and work together

12. Impact of Globalisation We need truly collaborative approaches both within and between –Industry and trade associations –Ingredients suppliers –Distributors –Regulators and Lawmakers –Criminal/Enforcement agencies

13. Resources IPEC –www.ipecamericas.orgwww.ipecamericas.org Download IPEC Guidance documents –Available for free (do need to register) –http://www.ipecamericas.org/public/registr ationform2.php?94,30http://www.ipecamericas.org/public/registr ationform2.php?94,30