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 February 8, 2013
EU Good Distribution Practice Guidelines 2013 |
Speaker for this Event:
Riekert Bruinink, Senior GMP/GDP Inspector,
Dutch Health Care Inspectorate, The Netherlands  |
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EU Good Distribution Practice Guidelines 2013
By January 2013 the renewed European GDP Guideline will be published. The existing directive (1994) will be thoroughly overhauled and adapted to the medicines distribution developments of the past 20 years. Major development changes regarding internationalization and globalization will make supply chain in this region more complex and risky.
This presentation will discuss the number of new and diverse items that will be included in the new directive (eg. validation, quality management and risk management). More guidance will be offered for topics such as temperature management and transportation.
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| THIS PROGRAM IS INTENDED FOR: |
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CEOs, Directors, VP, Heads and Team Leaders from
- Business Development: EU, USA
- Regulatory Affairs
- Good Distribution Practice
- Good Manufacturing Practice
- Validation
- Quality Management
- Quality Control
- Risk Management
- Supply Chain
- Logistics
- Transportation
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Riekert Bruinink, Senior GMP/GDP Inspector, Dutch Health Care Inspectorate, The Netherlands
Riekert Bruinink holds a MSc degree and Pharm D degree from the University of Utrecht, the Netherlands.
From 1981 to 1987 he worked as pharmacist in several public pharmacies. In 1987 he joined the Drug Inspectorate and in 1995 the Health Care Inspectorate in the Netherlands.
Riekert Bruinink held various positions , including management positions. He is now a GMP/GDP Senior Inspector and specializing in Good Distribution Practice. He is chairman of the PIC/s GDP working group since 2007 and member of the EMA GDP drafting Group. This group is responsible for making a proposal for a new EU GDP Guide and procedures for harmonizing GDP inspections in the European Union.
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