SERIALIZATION AND GOOD DISTRIBUTION PRACTICES: REGULATORY IMPACTS,OPPORTUNITIES AND CRITICALITIES FOR MANUFACTURERS AND DRUGS DISTRIBUTION CHAIN

ISPE AND PHARMINTECHEVENT HOSTED BY COSMOFARMA

FRIDAY, APRIL 17TH, 2015BOLOGNAFIERE, BOLOGNASINFONIA ROOM - 1ST FLOORMICHELINO ENTRANCE

ADMISSION FREE UPON REGISTRATION

TO PARTICIPATE FILL THE REGISTRATION FORM AND SEND IT:BY FAX TO PHARMINTECH:

+39 02 454708285

BY E-MAIL TO: ELENA.SANDRINI@COSMOFARMA.COM

Associazione Farmaceutici Ticinese

9:30 Registration

9:45 ISPE and Pharmintech Representatives presentation and welcome

9:55 Sponsors Representative welcome: AFTI, AUSED, PDA, UCIMA

10:10 Agenda presentation by the Chairman (Teresa Minero,Founder & CEO LifeBee & Vice President ISPE Italy) and the Co Chairman (Beppe Mazzocchi, Coding and Serialization Senior Oversight Group - EFPIA)

10:20 New regulations on drug production and distribution chain:10:20 GMDP, the new frontier of Quality

(Alessandro Piani, Executive Consultant - Pharma Quality Europe PQE) 10:45 Serializations Rules Updates from EU and rest of the 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 10’

11:45 - 12:00 Coffee Break

12:00 A case study on a Serialisation 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 Directive Medicine: it’s time to act now!(Beppe Mazzocchi, Coding and Serialization Senior Oversight Group - EFPIA)

Q&A 10’

13:10 - 14:00 Lunch

14:00 The journey to Serialization - how not to get lost, distractedbut 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 serialisation of medicines(Luc Adriaenssens, General Manager - APB Belgium Pharmacist Association)

15:00 The Italian association of Pharmacists point of view (Federfarma Representative)

Q&A 10’

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), logistic players (ASSORAM and ADF) and drug stores (APB and Federfarma) together with the Italian Regulatory Authority (AIFA)

16:20 - 16:30 Closing and Thanks

The day is conceived as an update and open discussion on newand upcoming regulations on Serialization and Track & Trace from all over the world (EU, China, Korea, Brazil, Saudi, USA,etc.), together with Good Distribution Practises, both having a significant impact on the whole Drug Supply Chain, from drug manufacturers to logistic players to the drug stores to all stakeholders.

The exchange of views and experience will involve AIFA, EFPIA, Pharma Industries, Consultants, Logistic Players and Pharmacists: all debating on regulatory impacts, but also on opportunities and criticalities generated by the newregulations compliance.

A round table will close the day highlighting different sectorassociations positions: drug producers (EFPIA), equipmentmanufacturers (UCIMA), logistic players (ASSORAM, otherinvited) and drug stores (APB and Federfarma) together with the Italian Regulatory Authority (AIFA).