During the summit, subjects necessary to design, commission and run a compounding facility will be presented in plenary sessions by experts.
Presenters will structure their presentation around 3 to 4 specific compounding processes. These are the topics of interest of the participants. Every participant will work in a group on their assigned topic over the two days of instruction and facilitation. The groups will present their response in a competitive environment.

At the end of the summit, the attendants should:

• Be able to realise of a state of the art facility for a specific compounding process in a European hospital pharmacy.
• Be able to organize and control the quality of this facility.
• Be able to develop a hospital prepared product and its packaging.
• Be able to identify legislation regarding compounding and if necessary to interpret it and formulate professional standards.
• Understand the risks of pharmacy compounding in relation to patient care and patient safety.
• have a general understanding of pharmacy preparation to support this task in their own situation
• have an overview of pharmacy prepared drugs in Europe, its state of the art regulations and its risks for patient safety.
• understand the concept of the SMF and will be able to write a SMF for their assigned topic
• understand the concept of a business plan and will be able to write one for their assigned topic.
• able to design a dedicated facility and will be able to validate equipment
• able to design a new product with an understanding of the concept “quality by design”
• able to understand the consequences of a change in administration form for a certain drug substance
• have an overview of the QA for a hospital pharmacy and will be able to design a VMP based on a risk evaluation
• able to use the concept of risk evaluation in QC on specific subjects
• introduced in the use several materials for packaging of medicinal products
• learn how to manage a GMP like organization

1. Introduction

Scope: explain the content of the course; define objectives; explain working rules, make up teams, short introduction by all participants, expectations by directors and by participants

Learning objectives: not specific

2. Scope and Definitions (plenary)

Scope: discuss the necessity of pharmacy prepared preparation and its role in patient care, discuss definitions used in Europe and present a proposal of uniform terms especially during the course

Learning objectives: participants will have a general understanding of pharmacy preparation to support this task in their own situation

3. Quality and safety of pharmacy prepared medicines (part 1 plenary) and Current understanding of medication errors associated with compounding (part 2 plenary)

Scope: clarification and update of the abridged survey report on Quality and safety of pharmacy prepared medicines by EDQM. Harmonization of standards, legal aspects, professional standards

Learning objectives: participants will have an overview of pharmacy prepared drugs in Europe, its state of the art regulations and its risks for patient safety.

4. Site master file (plenary followed by workshop)

Scope: explain the content and purpose of a SMF.

Workshop: prepare the SMF for the assigned topic, describe the organization, define products; describe the quality system

Learning objectives: participants will understand the concept of the SMF and will be able to write a SMF for their assigned topic

5. Business plan (plenary followed by workshop)

Scope: explain the content and purpose of a business plan.

Workshop: prepare the business plan for your assigned topic.

Learning objectives: participants will understand the concept of a business plan and will be able to write one for their assigned topic.

6. Premises and equipment (plenary followed by workshop)

Scope: describe design of premises; describe principle of URS, FRS, IQ, OQ, PQ, V-model)

Workshop: design the lay for your assigned topic

Learning objectives: participants will be able to design a dedicated facility and will be able to validate equipment

7. Product design (plenary)

Scope: how to design a preparation. Differences between standardized and non standardized, stock and individual; introduction to quality by design and design space.

Workshop: design products for your assigned topic

Learning objectives: participants will be able to design a new product with an understanding of the concept “quality by design”.

8. Biopharmaceutical aspects of compounding (plenary)

Scope: general introduction; administration form and absorption characteristics

Learning objectives: participants will be able to understand the consequences of a change in administration form for a certain drug substance.

9. Quality assurance (plenary followed by workshop)

Scope: general review, process control, interpretation of GMP, Validation Master Plan)

Workshop: VMP for your assigned topic

Learning objectives: participants will have an overview of the QA for a hospital pharmacy and will be able to design a VMP based on a risk evaluation.

10. Auditing and monitoring, quality control (plenary followed by workshop)

Scope: risk management, audit plan, monitoring (viable and non-viable)

Learning objectives: participants will be able to use the concept of risk evaluation in QC on specific subjects.

11. Packing materials in Hospital Pharmacy production

Scope: address plastic materials for the use in medicines as described in Ph.Eur.

Learning objectives: participants will be introduced in the use several materials for packaging of medicinal products.

12. Managerial aspects (plenary followed by workshop)

Scope: How to educate and train your personnel; how do you monitor this; possibility of outsourcing, SLA and outsourcing; how to handle a site inspection; staff competency

Workshop: prepare your site for an inspection; finalize your facility with your group

Learning objectives: participants will learn how to manage a GMP like organization