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~已截止,請至預約報名連結~2018/11/27 (星期二) ☆國際藥物安全監視研討會☆Pharmacovigilance System and Safety Data Exchange Agreement Workshop 4
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    隨著近年來某些新上市藥品因安全性等因素,藥物安全監視議題愈來越受到各國重視,國際相關法規亦日趨嚴謹,對於藥廠的藥物安全系統要求越來越明確,其中尤以歐盟相關法規的要求最為完整。

   
    本學苑非常榮幸邀請兩位德國專家來台演講,包括本學苑國際合作召集人,也是目前於任職於德國默克總部”全球患者安全部門”負責藥物安全協議的Liang-Ni Wu經理,以及在德國藥廠及CRO公司均有此領域相當豐富實務經驗的Meik Helmut Behrens博士。

   
    本研討會中兩位專家除了說明歐盟GVP規範、藥廠建立藥物安全監視系統的關鍵元素、藥廠安全資訊交換協議的重要性及主要內容,並以案例演練方式,讓與會者對上述議題有更深入的理解,本研討會對於在歐美等先進國家擁有藥物許可證者、代理經銷歐美等國家醫藥品者、協助國際藥廠代工/合作、醫藥品外銷歐美等國家等企業及其從業人員均有相當大的助益,期待藥界先進踴躍參與!

*****此次課程報名已截止,也請勿再填寫表單及匯款!謝謝!*****

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Pharmacovigilance System and Safety Data Exchange Agreement Workshop 
☆全英語研討會(Q&A可中文翻譯)


n   Organizer: Taiwan Salt and Light Biotech Institute (台灣光鹽生物科技學苑)

n   Date: 27th Nov 2018 (Tue.)

n   Time: 9:30-17:00

n   Venue: Salt and Light Conference Center (光鹽會議中心)

  Speakers

#Dr. Meik Helmut Behrens, Pharmacovigilance Expert from Germany, with more than 12 years of industrial experience of global drug safety /pharmacovigilance within a pharmaceutical company and contract research organization.

#Liang-Ni Wu, Pharmacovigilance Alliance Manager from Taiwan (based in Germany), with 6 years of industrial experience in medical writing / regulatory affairs and 9 years of drug safety/ pharmacovigilance experience within a pharmaceutical company and contract research organizations.

 

n   Workshop Content Details 

1.   
Importance of pharmacovigilance system and safety data exchange agreement for a pharmaceutical company(Liang-Ni Wu)

The pharmacovigilance quality system especially the procedures concerning the collection and management of safety information are often the focus points of pharmacovigilance inspections.

During this session, the speaker will introduce about the importance of having a pharmacovigilance quality system for a pharmaceutical company, and the necessity of having a safety data exchange agreement with other business partners.
Some terminology of pharmacovigilance for Taiwanese audience will also be explained in this session.

2.    European pharmacovigilance system requirements - EU requirements of pharmacovigilance system for marketing authorization holders, Good Pharmacovigilance Practice (GVP) modules(Dr. Meik Helmut Behrens)

The most comprehensive guidance about pharmacovigilance system is defined in the Good Pharmacovigilance Practice (GVP) by the European Union.

In this session, the speaker will give an introduction to the GVP modules and guide the audience through the EU requirements of pharmacovigilance quality system for marketing authorization holders.  

3.    Safety data exchange agreements - general contents and highlights on key sections (Liang-Ni Wu)

In this session, the speaker will introduce about the safety data exchange agreement, its general contents and give highlights on the key sections which are most relevant for most of the Taiwanese pharmaceutical companies.

4.    Pharmacovigilance procedures - key elements to build up the pharmacovigilance system(Dr. Meik Helmut Behrens)

In this session, the speaker will introduce about the key elements to build up the pharmacovigilance quality system.

     5.   Group discussion and panel discussion

 

n   Registration Fee: 4200 NT/person( Lunch and coffee/tea breaks included in registration fee)

n   On-line Registration : https://goo.gl/forms/HaXSvOoG8kxeyeSh2

   (報名方式:報名已截止)

 

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