Asphanews September!

cphi worldwide

Asphanews September!

 
 
Are you
attending CPhI 2017?

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

More info
 
 
 
Free
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. 

More info
 
 
 
 
 
 
Get an
exclusive 25% discount for the Global Pharmaceutical Regulatory Affairs Summit
2017

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” 

More info
 
 
 
 
FDA User
Fees were reauthorised

Food and Drug Administration Reauthorization Act
(FDARA) includes four medical product user fee programs.
More info
 
 
 
 
 
EMA
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
products.

More info
 
 
 
 
 
 
 
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

More info
 
 
 
 
 
 
 
Regulatory
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. 

More info
 
 
 
 
 
 
 
Asphalion
participated in the 8th General Assembly Meeting of the iHIVARNA’s project in
Paris

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

More info
 
 
 
 
 
 
World
Pharmacist Day 2017

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

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

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