Asphanews September!

cphi worldwide

Asphanews September!

Are you
attending CPhI 2017?

Visit Asphalion at booth 91B30
or arrange a meeting with us in advance!

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webinar on FDA Regulatory Affairs!

Based on the successful FDA Open Seminar conference series, we are hosting a 2
hour crash course webinar. We will cover the latest US drug regulation news and do a solid introduction to
the FDA Regulatory Affairs. 

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Get an
exclusive 25% discount for the Global Pharmaceutical Regulatory Affairs Summit

Use Asphalion’s VIP code CQ5267ION when registering and join us on October
24-26th in Prague. Our Regulatory Information Director, Remco Munnik, will
 speak about “The impact of IDMP on RA, with especial focus on
eSubmissions and RIM” 

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FDA User
Fees were reauthorised

Food and Drug Administration Reauthorization Act
(FDARA) includes four medical product user fee programs.
More info
implemented a new submission form for post-authorisation measures (PAM)

From 1st September 2017 the use of a new form is
mandatory for the submission of a PAM for centrally authorised medicinal

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How to
include the REMS for NDAs, ANDAs and BLAs in SPL format?

FDA has just released a guide to include them and it
will become mandatory in 2 years

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Information Management Systems round table

Join us on 19th October in Lüneburg, Germany.
David Kolosic, Asphalion Regulatory Information specialist will speak on the
topic Regulatory Information
Management – Challenges and Opportunities. 

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participated in the 8th General Assembly Meeting of the iHIVARNA’s project in

The meeting focused on the phase I clinical trial, the
ongoing phase II clinical trial, and next actions to be taken.

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Pharmacist Day 2017

Asphalion is joining the cause on September 25th to
highlight the great contributions the pharmacy profession is making to

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Meet us at:
2-4/10 TOPRA Annual Symposium,
London, UK
24-26/10 CPhI
, Frankfurt, DE –Stand 91B30
24-26/10 Global
Pharma Regulatory Affairs Summit
, Prague, CZ
6-8/11 BioEurope
, Berlin, DE
New FDA Gateway in Production Environment
World Pharmacists Day 2017

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