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Meet the NSF Health Sciences Team at the AFI Annual Symposium in Rimini, Italy from 12-14 June 2013, stand 76.

Monday the 3rd June 2013

NSF Health Sciences will have a strong presence at the AFI Symposium, including a Workshop on ICH Q10 and an exhibition stand where you can meet the NSF Health Sciences Division team of experts.

NSF Health Sciences’ expertise with in-house training offer clients customised training programmes that are designed to meet their specific needs (e.g. bringing about changes in existing practices, improvements in performance, and changes in quality management culture).The team’s expertise and experience include an in-depth knowledge of the requirements and expectations of the US FDA, the EMA and other major Health Authorities around the globe.

During the AFI Symposium, the NSF Health Sciences workshop will take place from 09:00 to 12:30 on Wednesday 12th June 2013. Stephen Engels (NSF-DBA Switzerland) and Giovanni Cosmi (NSF-DBA Italy) will cover the following:

“La linea guida Q10 sui Pharmaceutical Quality Systems : è solo un’ulteriore richiesta regolatoria o una nuova opportunità per le aziende farmaceutiche ?”

Stephen Engels has a Degree in Pharmacy and is a Principal Consultant with NSF Health Sciences. He has more than 25 year experience in Pharmaceutical Quality Management and is a Quality Management Systems expert. He has held several senior roles with Merck Serono in Switzerland, including most recently Head of Quality Programs & Systems Development, Quality Management, Technical Operations. With Merck Serono he created and implemented an auditor qualification and training programme, which was rolled out worldwide. He also has considerable experience of managing knowledge management concepts.

The title of the presentation Stephen Engels will deliver at the NSF Health Sciences Workshop is:

“Setting the Scene: Why the Need for ICH Q10 ?”

Giovanni Cosmi has a Degree in Chemistry and is a Consultant with NSF Health Sciences. He has over 22 years of diversified experience in Pharmaceutical Quality Operations management with several domestic and international companies. He is an experienced GxP compliance auditor for API, Drug Products and Cosmetics manufacturers. He has worked at operational and strategic levels within large organizations for the review, maintenance and improvement of Quality Systems to ensure compliance with the cGXP requirements against FDA and EMA expectations.

The title of the two presentations Giovanni Cosmi will deliver at the NSF Health Sciences Workshop are:

“ICH Q10 - Pharmaceutical Quality System” and “Where could ICH Q8, Q9 and Q10 take Us ?”

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