Serialization and Good Distribution Practices: Regulatory Impacts, Opportunities and Criticalities for Manufacturers and Drugs Distribution Chain

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1 Serialization and Good Distribution Practices: Regulatory Impacts, Opportunities and Criticalities for Manufacturers and Drugs Distribution Chain INTRODUCTION ISPE Italian Affiliate Bologna, April 17th

2 Agenda 9:45 Pharmintech & ISPE and Sponsor Welcome: AFTI, AUSED, PDA, UCIMA, AFI 10:10 Agenda presentation by the Chairman (Teresa Minero, Founder&CEO LifeBee & Vice President ISPE Italy) and the Co Chairman (Beppe Mazzocchi, EFPIA Coding and Serialization Senior Oversight Group) 10:20 GMDP, the new frontier of Quality (Alessandro Piani, Executive Consultant - Pharma Quality Europe PQE) 10:45 Serializations Rules Updates from EU & world (Giada Necci, New Solution Specialist - GS1 Italy Indicod-Ecr) 11:10 The view of the Italian Regulatory Authority (Domenico Di Giorgio, Direttore Ufficio Qualità dei Prodotti -AIFA) Q&A :45-12:00 Coffee Break 12:00 A case study on a Serialization project by a Drug Manufacturer (Mario R. Scigliano, Serialization PMO & Project Leader - Corden Pharma) 12:20 Increase patient's safety through implementation of new requirements on GDP and drugs traceability (Alberto Bartolini, Supply Chain area coordinator - AFI) 12:40 Falsified Medicine Directive: it s time to act now! (Beppe Mazzocchi, Coding and Serialization Senior Oversight Group - EFPIA) 13:10-14:00 Lunch 14:00 The journey to Serialization - how not to get lost, distracted but stay on course to success (Christoph Krähenbühl, Director - 3C Integrity Consulting Ltd) 14:20 Serialization in GDP scope: the importance of traceability in the distribution process (Luca De Toro, Quality & Customer Satisfaction Manager - STM Group) 14:40 The Belgian experience with serialization of medicines (Luc Adriaenssens, General Manager - APB Belgium Pharmacist Association) 15:00 The Italian association of Pharmacists point of view (R. Tobia - Federfarma Representative) 15:20 Opportunities and criticalities created by serialization and GDP to all the Supply Chain actors, from production to drug stores (Introduction to the Round Table by the Chairman) 15:30 Round Table with representatives of Associations of drug producers (EFPIA), equipment manufacturers (UCIMA), Deposits (ASSORAM) and Wholesaler s (ADF) and drug stores (APB and Federfarma ) together with the Italian Regulatory Authority (AIFA) 16:40-16:30 Closing and Thanks ISPE & Pharmintech Agenda 2

3 Agenda 9:45 Pharmintech & ISPE and Sponsor Welcome: AFTI, AUSED, PDA, UCIMA, AFI 10:10 Agenda presentation by the Chairman (Teresa Minero, Founder&CEO LifeBee & Vice President ISPE Italy) and the Co Chairman (Beppe Mazzocchi, EFPIA Coding and Serialization Senior Oversight Group) 10:20 GMDP, the new frontier of Quality (Alessandro Piani, Executive Consultant - Pharma Quality Europe PQE) 10:45 Serializations Rules Updates from EU & world (Giada Necci, New Solution Specialist - GS1 Italy Indicod-Ecr) 11:10 The view of the Italian Regulatory Authority (Domenico Di Giorgio, Direttore Ufficio Qualità dei Prodotti -AIFA) Q&A :45-12:00 Coffee Break 12:00 A case study on a Serialization project by a Drug Manufacturer (Mario R. Scigliano, Serialization PMO & Project Leader - Corden Pharma) 12:20 Increase patient's safety through implementation of new requirements on GDP and drugs traceability (Alberto Bartolini, Supply Chain area coordinator - AFI) 12:40 Falsified Medicine Directive: it s time to act now! (Beppe Mazzocchi, Coding and Serialization Senior Oversight Group - EFPIA) 13:10-14:00 Lunch 14:00 The journey to Serialization - how not to get lost, distracted but stay on course to success (Christoph Krähenbühl, Director - 3C Integrity Consulting Ltd) 14:20 Serialization in GDP scope: the importance of traceability in the distribution process (Luca De Toro, Quality & Customer Satisfaction Manager - STM Group) 14:40 The Belgian experience with serialization of medicines (Luc Adriaenssens, General Manager - APB Belgium Pharmacist Association) 15:00 The Italian association of Pharmacists point of view (R. Tobia - Federfarma Representative) 15:20 Opportunities and criticalities created by serialization and GDP to all the Supply Chain actors, from production to drug stores (Introduction to the Round Table by the Chairman) 15:30 Round Table with representatives of Associations of drug producers (EFPIA), equipment manufacturers (UCIMA), Deposits (ASSORAM) and Wholesaler s (ADF) and drug stores (APB and Federfarma ) together with the Italian Regulatory Authority (AIFA) 16:40-16:30 Closing and Thanks ISPE & Pharmintech Agenda 3

4 Ma prima una consapevolezza ISPE & Pharmintech Introduction Teresa Minero 4

5 Ma anche un punto di attenzione * Many serialization and brand protection leaders lack a complete understanding of the functionality and benefits Short-term compliance milestones are driving decisions to deploy serialization capabilities, leading supply chain leaders to overlook the longer-term benefits of brand protection and improved network coordination, in the push to meet timelines * Source Gartner 2014 & 2015 ISPE & Pharmintech Introduction Teresa Minero 5

6 Agenda 9:45 Pharmintech & ISPE and Sponsor Welcome: AFTI, AUSED, PDA, UCIMA, AFI 10:10 Agenda presentation by the Chairman (Teresa Minero, Founder&CEO LifeBee & Vice President ISPE Italy) and the Co Chairman (Beppe Mazzocchi, EFPIA Coding and Serialization Senior Oversight Group) 10:20 GMDP, the new frontier of Quality (Alessandro Piani, Executive Consultant - Pharma Quality Europe PQE) 10:45 Serializations Rules Updates from EU & world (Giada Necci, New Solution Specialist - GS1 Italy Indicod-Ecr) 11:10 The view of the Italian Regulatory Authority (Domenico Di Giorgio, Direttore Ufficio Qualità dei Prodotti -AIFA) Q&A :45-12:00 Coffee Break 12:00 A case study on a Serialization project by a Drug Manufacturer (Mario R. Scigliano, Serialization PMO & Project Leader - Corden Pharma) 12:20 Increase patient's safety through implementation of new requirements on GDP and drugs traceability (Alberto Bartolini, Supply Chain area coordinator - AFI) 12:40 Falsified Medicine Directive : it s time to act now! (Beppe Mazzocchi, Coding and Serialization Senior Oversight Group - EFPIA) 13:10-14:00 Lunch 14:00 The journey to Serialization - how not to get lost, distracted but stay on course to success (Christoph Krähenbühl, Director - 3C Integrity Consulting Ltd) 14:20 Serialization in GDP scope: the importance of traceability in the distribution process (Luca De Toro, Quality & Customer Satisfaction Manager - STM Group) 14:40 The Belgian experience with serialization of medicines (Luc Adriaenssens, General Manager - APB Belgium Pharmacist Association) 15:00 The Italian association of Pharmacists point of view (R. Tobia - Federfarma Representative) 15:20 Opportunities and criticalities created by serialization and GDP to all the Supply Chain actors, from production to drug stores (Introduction to the Round Table by the Chairman) 15:30 Round Table with representatives of Associations of drug producers (EFPIA), equipment manufacturers (UCIMA), Deposits (ASSORAM) and Wholesaler s (ADF) and drug stores (APB and Federfarma ) together with the Italian Regulatory Authority (AIFA) 16:40-16:30 Closing and Thanks ISPE & Pharmintech Agenda 6

7 Ed ora qualche istruzione per la giornata: Comincio con un grazie a Pharmintech per la organizzazione logistica e per la ospitalità, a Beppe Mazzocchi, co-chairman della giornata per la disponibilità e il prezioso contributo alla revisione delle presentazioni, a AFI, AFTI, AUSED, AUSED PDA per il patrocinio e ai relatori per gli importanti contributi, a tutti e numerosi partecipanti Interventi nei limiti di tempo definiti dalla agenda per lasciare spazio a domande Puntualità nel rientro dai break E poi per le sessioni di Q&A e per la tavola rotonda esortiamo tutti a fare domande ed a aiutarci a far sì che sia davvero una giornata di studio e di confronto, domande attinenti l intervento alla fine di ognuno, domande generali e dibattito alla tavola rotonda! Compilare TUTTI il questionario relativo all evento (cerchiamo sempre il miglioramento continuo, anche nella organizzazione degli eventi!) Le presentazioni potranno essere richieste tra una settimana via mail alla segreteria ISPE: ISPE & Pharmintech Introduction Teresa Minero 7

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