10:30 - 10:45

Chairman: Ton Capella

Pharmaprocess President/CEO Azbil Telstar


Good Distribution Practices for APIS. A view on GDP compliance expectations (Organized by AEFI - Catalan Section)

10:45 - 11:00

Risk Management for chain distribution. A pragmatic approach

Speaker: Mercedes Carrera

Spanish SHEQ Manager Azelis España S.A.

11:15 - 11:30

Route risk assessment for transport

Speaker: Antonio López

UPS-EMEA Business Development Manager Healthcare

11:30 - 11:45

New regulatory requirements for API manufacturers

Speaker: Jordi Valls

Chief Technical Officer/Technical Manager – Moehs Ibérica S.L 

11:45 - 12:00

Q & A

TTIP & Industry 4.0

12:00 - 12:30

Industry 4.0 + Innovation = Challenge for the pharma industry. How the cloud and big data solve the equation. 

Speaker: Toni Manzano

CSO - Bigfinite

12:30 - 13:10

Keynote: Object Oriented Manufacturing within Pharma

Speaker: Didier Caudron

Director Global Process Control, Modeling and Simulation - IO/GESS - Sanofi Pasteur

13:10 - 13:30

Q & A

Facility & Process standardization, focus to improve: Timings, Capex & Cost of Ownership

13:30 - 14:00

Speaker: José Arlandis

Continuous improvement Manager, Project Manager K Lean, Kern Pharma

14:00 - 14:40

Keynote: Equipment standardization & end asset life cycle management. 

Speaker: Isnel Ducos

Executive Director, Global Capital & Packaging equipment Merck, Sharp & Dohme

14:40 - 15:00

Q & A


Pharmaprocess powered by Expoquimia, together with CPHI, want to show the latest trends in the optimization of the pharmaceutical industry. Pharmaprocess forum offered you a full range of learning opportunities to help you to enhance your business. In-depth sessions and specialist topics with the main experts of the pharmaceutical industry. PharmaProcess is committed to increasing the efficiency of manufacturing processes

In the hands of the best experts in the sector, topics like TIPP & Industry 4.0 would be treated, and the most disruptive talks in Facility & Process Standardization focus to Improve: Timings, Capex & Cost of Ownership will take place next October 6th, 2016 in THEATHER 1.

Please don't miss the opportunity to meet us, and enjoy a state of the art experience in the Pharma sector.

SESSION 1: Good Distribution Practices for APIS. A view on GDP compliance expectations

Good Manufacturing Practice (GMP) is a vital component of Quality Assurance which helps to ensure that medicinal products are consistently produced with the quality standards appropriate for their intended use. Under the Medicines Act, all manufacturers and assemblers of medicinal products (both "Western Medicines" and "Chinese Proprietary Medicines" (CPM)) are required to conform to GMP. As a member of PIC/S, HSA's GMP auditors will conduct audits on medicinal product manufacturers and assemblers in accordance with the PIC/S Guide to GMP for Medicinal Products (Part I) and its relevant annexes, which encompasses all the recommendations of the World Health Organization (WHO) in relation to GMP.

Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. Products must:

  • • be of consistent high quality
  • • be appropriate to their intended use
  • • meet the requirements of the marketing authorization (MA) or product specification

Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification. Organizations that may have to comply with good manufacturing practice (GMP) and/or good distribution practice (GDP) include:

  • • manufacturer license holders
  • • wholesale dealer license holders
  • • blood establishment authorization holders

Institutional body's carries out inspections to check if manufacturing and distribution sites comply with GMP or GDP. You will be inspected when you apply for a manufacturer or wholesaler dealer license and then periodically based on risk assessments. Overseas manufacturing sites are also inspected.

SESSION 2: TTIP & Industry 4.0

Trends are always welcome in industry even though I maintain that we must constantly innovate to anticipate the trends. It takes a lot to establish a trend that might be important as regards getting good results for the manufacturing system. And so it is now with the Industry 4.0 revolution. I have faith in this trend. But I have even more faith in the companies that are already ahead of the challenge and are preparing the future for industry.

This "new" concept of Industry 4.0 is based, as we all know, focused at that time on establishing priority areas for R&D in the manufacturing. And the idea was to lead the trends towards a new type of industrialisation, focused on the machinery, production tools and industrial processes with obvious consequences on working methods and procedures, production lines, market strategies and the skills and human resources needed to embrace the huge challenge.

There are also two very important issues in this "revolution". On the one hand, the components evolution (not only the electronic parts and the dimension associated with this – nanotechnologies and so on – but also other parts with multiple digital uses and low costs) and its interaction with other components and computers – the so-called internet of things. This will have huge consequences for production lines and processes.

Technology is already present in our daily life and the need to combine technologies (available or not) like 3D-printing, the mobile, cloud computing and augmented reality will be the secret to maintaining competiveness in a world that is calling for industrial customisation but at the same time, with companies that still need to play a role in mass production.

In addition to the theme of an Integrated Industry, another topic that emerged last week was the Transatlantic Trade and Investment Partnership (TTIP), which would join the United States and the European Union (EU) in the worlds largest economic and trade partnership.

SESSION 3: Facility & Process standardization, focus to improve: Timings, Capex & Cost of Ownership

It's no secret that cost overruns and delays run rampant in large capital projects. Research points the finger at decision biases, which often play an important role in skewing the forecasting of costs and timing as projects are being planned. But a lack of internal discipline, in both the proposal and management stages of a project, further raises costs—both of individual projects and entire portfolios of investment.

A competitive product must address factors such as cost, performance, aesthetics, schedule or time-to-market, and quality. The importance of these factors will vary from product to product and market to market. And over time, customers or users of a product will demand more and more, e.g., more performance at less cost.
Cost will become a more important factor in the purchase or acquisition of a product in two situations.

First, as the technology or aesthetics of a product matures or stabilizes and the competitive playing field levels, competition is increasingly based on cost or price.
Second, a customer's internal economics or financial resource limitations may shift the acquisition decision toward affordability as a more dominant factor.
In either case, a successful product developer must focus more attention on managing product cost.

The management of product cost begins with the conception of a new product. Typically sixty to seventy percent of a product's cost or life cycle costs are committed based on decisions made during concept or architecture development. Eighty-five to ninety percent of a product's cost or life cycle cost is committed by the time that the product has been designed and its manufacturing process has been developed. Potential actions related to manufacturing initiatives, automation, overhead reductions, and general and administrative expenses may only affect the remaining ten to fifteen percent of the product's cost.

Since the decisions made during the product development cycle account for seventy to eighty percent of product costs, product cost management must begin with the start of product development. Product development personnel must understand competitive pricing or customer affordability requirements. Target costs must be established at the start and used to guide decision-making. Development personnel must operate as entrepreneurs in making hard decisions about the product and process design to achieve target costs. Cost models must be provided to support decision-making early in the development cycle. And the quality of information and the cost models must be continually improved and refined. This increased focus on product or life cycle costs will lead to significantly reduced costs and more satisfied customers