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Plenary session
Key elements of the pharmaceut ical regulatory system
Wayne Müller
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Strengthening reliance practices in regulation of medicinal products international regulatory collaboration between countries
Dr. Theingi Zin
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Strengthening reliance practices in regulation of medicinal products international regulatory collaboration between countries
Darwin Marcelo
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Global regulatory requirements should there be any and those who make them
Dmitry Galkin
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Experiences of regulatory cooperation international between countries
Dr. Medard Kab Bitekyerezo
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Experiences of regulatory cooperation international between countries
Lisette Perez Ojeda
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International regulatory harmonization implementation of international standards into the regulatory system
Aziz Dusmatov
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Expert session
Implementation of Annex 1 (Manufacture of sterile medicinal products) advantages and difficulties
Wayne Muller
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Highlights of ISPE's Baseline® Guide Commissioning and Qualification
Banu Refik
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Cross Contamination Risks
George Derzskiy
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Manufacture of sterile medicinal products lyophilisation processes and associated risks
Yulia Niorba
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Role of International Guidelines and Recommendations in Ensuring a Harmonized Approach to the Technical Interpretation of GMP requirements
Vladimir Orlov
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GAPI working groups
Vladimir Smirnov
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