VIGILEX.NL

Vigilex - Introduction to Vigilex

As Europe`s first Contract Safety Surveillance Organisation (CSO), Vigilex recognises that, in the ever-changing landscape of regulatory requirements for products under development (pre-authorisation) and authorised products (post-authorisation), patient safety and compliance are key to the industry. Vigilex pursues non-exclusive partnerships in specialist areas where we feel clients may benefit. For information about the Xendo group: http:/ www.xendo.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

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Vigilex - Introduction to Vigilex | vigilex.nl Reviews

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As Europe`s first Contract Safety Surveillance Organisation (CSO), Vigilex recognises that, in the ever-changing landscape of regulatory requirements for products under development (pre-authorisation) and authorised products (post-authorisation), patient safety and compliance are key to the industry. Vigilex pursues non-exclusive partnerships in specialist areas where we feel clients may benefit. For information about the Xendo group: http:/ www.xendo.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

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5 adverse event management

6 periodic reports

7 safety procedures

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Vigilex - Introduction to Vigilex | vigilex.nl Reviews

https://vigilex.nl

As Europe`s first Contract Safety Surveillance Organisation (CSO), Vigilex recognises that, in the ever-changing landscape of regulatory requirements for products under development (pre-authorisation) and authorised products (post-authorisation), patient safety and compliance are key to the industry. Vigilex pursues non-exclusive partnerships in specialist areas where we feel clients may benefit. For information about the Xendo group: http:/ www.xendo.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

INTERNAL PAGES

vigilex.nl

1

Vigilex - Inspection Preparedness

http://www.vigilex.nl/en-613/inspection-preparedness-.htm

Sandra van der Poel - Smet. T: 31 (0)71 524 40 00. Over the past years, competent authorities have increased and intensified their regulatory inspections. As support to clients during their preparation for these inspections, Vigilex has developed proven concept for inspection preparedness training. This training is usually conducted in-house and aims to ensure that staff are aware what is expected during interviews and how to conduct themselves during an inspection.

2

Vigilex - New PVA template

http://www.vigilex.nl/en-368/new-pva-template.htm

We have updated our Pharmacovigilance Agreement (PVA) template for license agreements, to comply with the currently known new requirements contained in the GVP guidelines. The template provides an excellent basis to re-structure your PVAs with License and other partners with clear and concise text as to what is required. If you are interested please contact: mail@vigilex.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

3

Vigilex - News

http://www.vigilex.nl/en-6/news.htm

10032014 - New PVA Template. We have updated our Pharmacovigilance Agreement (PVA) template for license agreements. Vigilex 31(0)71 524 4000 mail@vigilex.com.

4

Vigilex - Introduction to Vigilex

http://www.vigilex.nl/en-1/home.htm

As Europe`s first Contract Safety Surveillance Organisation (CSO), Vigilex recognises that, in the ever-changing landscape of regulatory requirements for products under development (pre-authorisation) and authorised products (post-authorisation), patient safety and compliance are key to the industry. Vigilex pursues non-exclusive partnerships in specialist areas where we feel clients may benefit. For information about the Xendo group: http:/ www.xendo.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

5

Vigilex - Vigilex in Japan

http://www.vigilex.nl/en-638/vigilex-in-japan.htm

12532;ィジレックスは、顧客が恩恵を受けることができると考えられる専門的な領域において、非独占的なパートナーシップを築いています。 12503;ロフィール. 12532;ィジレックスを選択することにより、顧客は人員増加およびインフラ整備のコストの増加なしに、内部のリソースと&#1250...12481;ーム. 12532;ィジレックスの上級スタッフは、国内および国際的なカンファレンスで定期的に講演を行ってお&...31169;達のスタッフは、私達が提供するサービスを更に発展させ、全ての顧客と成功裏&#12...12532;ィジレックスは現在、以下の分野での国際的・実務的経験と専門性&#1...12288;－　EU QPPV、deputy EU QPPV、ヨーロッパ国内QPPV. 12288;－　有害事象管理. 12532;ィジレックスはヨーロッパのいくつか&#123...12414;でEメールでお送り下さい。 23451;てにお願い致します。 25152;在地. Tel: 81 (0)90 5257 4222. Fax: 81 (0)3 3534 7664.

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Vigilex - Introduction to Vigilex

As Europe`s first Contract Safety Surveillance Organisation (CSO), Vigilex recognises that, in the ever-changing landscape of regulatory requirements for products under development (pre-authorisation) and authorised products (post-authorisation), patient safety and compliance are key to the industry. Vigilex pursues non-exclusive partnerships in specialist areas where we feel clients may benefit. For information about the Xendo group: http:/ www.xendo.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

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Vigilex - Introduction to Vigilex

As Europe`s first Contract Safety Surveillance Organisation (CSO), Vigilex recognises that, in the ever-changing landscape of regulatory requirements for products under development (pre-authorisation) and authorised products (post-authorisation), patient safety and compliance are key to the industry. Vigilex pursues non-exclusive partnerships in specialist areas where we feel clients may benefit. For information about the Xendo group: http:/ www.xendo.com. Vigilex 31(0)71 524 4000 mail@vigilex.com.

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