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NGB Symposium: Compounding as a specialism: a European perspective

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Patients in Europe can usually purchase medicines manufactured by pharmaceutical companies. These manufacturers must first obtain a marketing authorisation for their medicines before their medicines can be marketed. In this way, quality, safety and effectiveness are guaranteed.

However, in specific cases, registered medicines are not suitable for patients and their disorders. In these situations, a medicine prepared by a pharmacy can be used as an alternative: the pharmacy preparation. Because the preparation of medicines is a complex task, in the Netherlands and other European countries these pharmacy preparations are nowadays often made by specialised compounding pharmacies.
For pharmacy preparations, a good balance between risks, effectiveness and quality is also important. Regulation is therefore necessary.

The practice of compounding pharmacy preparations and the inspection thereof by the relevant governmental authorities has developed differently in the various European countries.
In 2016 the Council of Europe published the Resolution on quality and safety assurance requirements for medicinal products for special needs in pharmacies. This resolution can be used as a guideline by European countries when regulating and supervising the compounding, quality and availability of medicines.
In addition, a number of court cases have been conducted about whether or not the preparation of a specific medicine is justified in relation to the availability of registered medicines. Some of these court cases have led to relevant case law.

The Network for Specialised Compounding Pharmacies (NGB) is  a branch organisation for specialised compounding pharmacies and as such aims to be a point of contact and a collaboration partner for field parties concerning compounding. The NGB organises this symposium on compounding as a specialism in a European perspective to:

  • Stimulate the discussion about the law and regulatory framework and business climate for compounding in Europe.
  • Stimulate cooperation with other European branch organisations in order to create a European compounding umbrella organization.
  •  Develop recommendations regarding the law and regulatory framework to:
  •  Promote equal accessibility to pharmacy preparations for European patients,
  •  Secure equal quality of pharmacy preparations for European patients,
  •  Encourage a level playing field to area of compounding in Europe.
  •  Explain, preserve and expand the value that compounding pharmacies can offer to patients in addition to registered medicines.

This symposium aims to:

  • Highlight a number of examples of national interpretations of regulation and supervision of the compounding of specific medicines and to draw lessons from this for a best practice.
  • Develop recommendations for the harmonisation of European regulations concerning the compounding of specific medicines.
  • Provide insight into the European regulations on pharmacy preparations.
  • Provide insight into the practical interpretation of the concept of availability in various European countries.
  • Provide insight into how the quality of pharmacy preparations can be adequately safeguarded.
  • Provide insight into how the interests of manufacturers of registered medicines, who have borne all the costs of clinical research and registration, can be protected?

9.00-9.30        Welcome

9.30-10.00      Opening and introduction

10.00-10.45    Compounding in the UK, Jonathan Fawdry

10.45-11.05    Coffee break

11.05-11.50    Compounding in Belgium, Michel Forier

11.50-12.35    The ins and outs of the landmark Abcur case, Roger Tapper

12.35-13.35    Lunch & networking

13.35-14.20    Regulatory framework regarding compounding,
Maarten Meulenbelt & Koosje van Lessen Kloeke

14.20-15.05    Perspective of the pharmaceutical industry, TBA

15.05-15.25    Coffee break

15.25-16.10    Compounding in the Netherlands, TBA

16.10-16.40    Panel discussion

16.40-16.55    Wrap up and conclusion by the chairman

16.55-17.55    Drinks en networking

HollandBIO members can get 20% discount

There’s a discount of €25,- (20%) for HollandBIO members. Please contact HollandBIO’s Robbert if you’re interested.