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Biotechnology impact into the
pharmaceutical industry: a radical
change
Design of Modular Facilities
October 29, 2013, Tuesday
PHARMAPROCESS 2013
Development Biopharmatech Operations
Reception
Acto Inaugural HORIZON 2020
Solid Development, PAT techniques
"CLOUD SUPPLY CHAIN INFORMATION
SYSTEM", is the future?
PLENARY Anti falsification, what's the Strategy in place?
ProcessBiopharmatech
October 30, 2013, Wednesday
Developmnet
Lunch
Novel excipients. Regulatory: Cellular Therapies
Coffe break y Visita Expositores
Patient drug safety 2.0
Biocatalysis: moving chemical and
pharmaceutical production further
Jumping for a continous production
Lunch
Active ingredients, can we beleave in
them?
PLENARY Demand planning + SO&P process, a key success factor on supply.
Capsulas Premio Capsulas Premio Capsulas Premio
Break y Visita Expositores
Personalized Medicines for XXI
century
Animal cell technology: the enabling
platform for pharmaceutical drug
production
How to optimize the supply chain model.
Looking outside.
Excipient quality: an FDA / EMA
perspective.
Challenges and new technologies in
bioprocess: matching bioprocess
capacities to market demands
Reception
Break y Visita Expositores
Platform for innovative medicines Biosimilars
Guarantee for a World supply of
medicines . Medicinal Shortages due to
manufacturing and quality problems
Inspection. Does the frontiers ensure the
safety of the incoming products?
How to Register a Dossier for a
Generic in USA (Q8,Q9,Q10,Qn+1)
Coffe break y Visita Expositores
Nanotechnology and drug delivery:
redesigning pharma process

2. Excipient quality: an FDA / EMA perspective.
Contraste de puntos de vista entre FDA y EMEA sobre la calidad de los excipientes
Speech:Dr. Ian Moore Head of Global Quality Assurance at Croda and President of EXCiPact iain.moore@croda.com
Presentacion: Beatriz Artalejo
Novel excipients.
Calidad y retos de nuevos excipientes, perspectiva Europea
Speech: Mr. Carl Mroz ( Colorcon ) cmroz@colorcon.co.uk
Presentacion: csanjuan@colorcon.com ( Carlos San Juan, contacto para invitacion)
Patient drug safety 2.0
Normativa Europea.Nuevo papel del paciente en farmacovigilancia.
Speech: (Cristina Irala) c.deirala@viglya.com alguien MHRA y OCU?.
Presentacion:
Solid Development, PAT techniques
Ultimos avances en desarrollo de productos.Procesos continuos
Speech: GEA Mr. Tomas Vermeire - Senior Process Technologist - Lighthouse Probe Product Manager
Presentacion: Miguel Sambola (Miguel.sambola@gea.com) contacto para invitacion
Personalized Medicines for XXI century
Medicamentos de futuro. Cambios en la sistemática para la obtencion de nuevos medicamentos.
Speech: Olga Fidalgo ofidalgo@ferrergrupo.com
Presentacion:
Platform for innovative medicines
Caso practico de aplicación en el desarrollo de nuevos productos.Optimizacion de recursos.
Speech: Novartis Madrid o MIT
Presentacion:
How to Register a Dossier for a Generic in USA (Q8,Q9,Q10,Qn+1)
Registro de genericos en USA.Exigencias practicas para su registro y comercializacion.
Speech: Inna Ben Anat, "QbD Strategy Leader at Teva Pharmaceuticals".
Presentacion: Alicia Tebar
DEVELOPMENT

3. Biotechnology impact into the pharmaceutical industry: a radical change Dr. Jordi Martí, Cellgene CEO (former CEO of Amgen Spain) jmarti@celgene.com
Biocatalysis: moving chemical and pharmaceutical production further Speech:
Dr. Pierre Monsan, Director Toulouse White Biotechnology (TWB) & Deputy Director of the
Laboratory of Biological Systems Engineering and Processes, INSA, Toulouse.
Pierre.Monsan@insa-toulouse.fr
Presentation:
Dr. Josep Castells, Inkemia/IUCT josep@iuct.net
Animal cell technology: the enabling platform for pharmaceutical drug production Speech:
Dr. Andy Racher Head of Process Development Sciences at Lonza aracher@lonza.co.uk
Challenges and new technologies in bioprocess: matching bioprocess capacities to market demands Round table:
ALAIN BERNARD (UCB) alain.Bernard@ucb.com
Moderator:
Dr. Francesc Godia (UAB) francesc.godia@uab.cat
Nanotechnology and drug delivery: redesigning pharma process Dra. Teresa Pellegrino (National Nanotechnology Laboratory of CNR-INFM di Lecce, Italia)
teresa.pellegrino@unisalento.it
Regulatory: Cellular Therapies Dr. Xavier Luria, (Independent Consultant Drug Development & Drug Regulation, former member of
EMA) xavierlluria@ddrmedic.com
Biosimilars
Dr. Fernando de Mora, professor of Farmacology at UAB fernando.demora@uab.cat
Biosimilars are the "generics" of biological drugs but neither their production nor their regulatory framework make it easy to
produce biosimilars. How to maximize opportunities and overcome hudles?
Cell therapies, those based on human cells, tissues, and cellular and tissue-based products (HCT/Ps), confront several
challenges and constraints in their regulatory pathway both in Europe and US. This conference is intended to review the main
regulatory issues related with advanced therapies
Nanotechnology has the potential of literally revolutionize drug delivery. Right now, systems like liposomes, polymeric micelles,
and nanoparticles are called “nanovehicles”, but this is correct only in the size scale. The importance of nanotechnology in drug
delivery is in the ability to manipulate molecules and supramolecular structures for producing devices with programmed
functions
BIOPHARMATECH
Two great challenges in modern biotechnology production systems are, on one hand, how to manage the production capacity
(adapting factories and systems dimensions to pipelines and combining companies' own production capacities with CMO
services) and, on the other, the introduction of single use manufacturing models.
Which are the last developments in culture cells technologies for the production of biological molecules? The increased
demand for biopharmaceuticals requires scaling production capacity and facilities.
How is industrial biotech transforming drugs production?. State of the art and new developments

4. PLENARY Demand planning + SO&P process, a key success factor on supply.
How to manage the excellence on supply.
Speech Jaume Cubero ( jaume.cubero@mylan.com)
montserrat.marimon@nutritionetsante.com
Gary Johnson gary@inpharmation.co.uk)
Moderador:
Design of Modular Facilities
The new flexible site
Speech : Dr. Paul Stewart ( pstewart@telstar.eu )
Presentacion: Rafa Beaus
Active ingredients, can we beleave in them?
Development challenges, fast access to market, co-development, homologation issues
Speech Santi Alonso (aloneste@gmail.com),
Belen Crespo (Directora de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).sdaem@msssi.es
Moderator: Rafa Beaus (rbeaus001@cofb.net)
Inspection. Does the frontiers ensure the safety of the incoming products?
International overview on the frontiers for incoming safety goods.
Ponentes: Cristina Batlle cristina.batlle@seap.minhap.es
Inspector Rotterdam + Empresa
Moderador Belen Escribano (Jefa del Departamento de Inspección y Control de Medicamentos. AEMPS) bescribanor@aemps.es
Jumping for a continous production
"Solid developmnet, PAT techniques" at industrial level
Speech: GEA Mr. Michael Van Den Bossche. Sales Manager, GEA Pharma Systems, Collette™
Presentacion: Miguel Sambola (Miguel.sambola@gea.com) contacto para invitacion.
PLENARY Anti falsification, what's the Strategy in place?
European situation on anti falsification. Where we are, what we do.
Speech: Belen Escribano (Jefa del Departamento de Inspección y Control de Medicamentos. AEMPS) bescribanor@aemps.es
Martin Friedrich de EFPIA martin.friedrich@bayer.com
Moderador:
How to optimize the supply chain model. Looking outside.
Looking outside the Pharma supply world.
Ponentes: Manel Jimenez m.jimenez@desigual.com
Presentacion:
"CLOUD SUPPLY CHAIN INFORMATION SYSTEM", is the future?
Ponentes: GT NEXUS o CAP GEMINI information@gtnexus.com
Presentacion: Shabbir Dahod es tracelink President and CEO (responsable de la cuenta de Pfizer)
Greg Kefer es Corporate Marketing Vice President.
Guarantee for a World supply of medicines . Medicinal Shortages due to manufacturing and quality problems
How tu ensure the medicines around the World?
Ponentes: Mr. Brendan Cuddy, Scientific Administrator, Compliance and Inspection Sector
Presentacion: Salvador Cassany
Operations