SERIALIZATION AND
GOOD DISTRIBUTION
PRACTICES:
REGULATORY IMPACTS,
OPPORTUNITIES
AND CRITICALITIES
FOR MANUFACTURERS
AND DRUGS
DISTRIBUTION CHAIN
ISPE AND PHARMINTECH EVENT
HOSTED BY
COSMOFARMA
FRIDAY, APRIL 17TH, 2015
BOLOGNAFIERE, BOLOGNA
SINFONIA ROOM - 1ST FLOOR
MICHELINO ENTRANCE
9:30
Registration
9:45
ISPE and Pharmintech Representatives presentation and welcome
9:55
Sponsors Representative 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, 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
Associazione
Farmaceutici Ticinese
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 serialisation of medicines
(Luc Adriaenssens, General Manager - APB Belgium Pharmacist Association)
15:00 The Italian association of Pharmacists point of view
(Roberto Tobia, Presidente Federfarma Palermo - FEDERFARMA)
ADMISSION FREE UPON REGISTRATION
TO PARTECIPATE FILL IN THE ENCLOSED
FORM AND SEND IT:
BY FAX TO PHARMINTECH:
+39 02 454708285
BY E-MAIL TO:
ELENA.SANDRINI@COSMOFARMA.COM
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