Asphanews September!
Are you attending CPhI 2017?
Visit Asphalion at booth 91B30 or arrange a meeting with us in advance!
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.
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”
FDA User Fees were reauthorised
Food and Drug Administration Reauthorization Act (FDARA) includes four medical product user fee programs.
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.
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.
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.
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.
World Pharmacist Day 2017
Asphalion is joining the cause on September 25th to highlight the great contributions the pharmacy profession is making to healthcare.
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
