Latest news from Exalon and updates from Regulators, Pharmaceutical Industry and other Stakeholders.
Radolfzell (Germany)
Joined March 2010
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exalon retweeted
Association for Accessible Medicines took issue with the fact that FDA continues to ask sponsors to list electronic common technical document (eCTD) modules containing facility information, which it said “seems unnecessary” to dete…lnkd.in/eZjiqcU8 lnkd.in/eMAYEsin
exalon retweeted
🔵Don’t underestimate the lifesaving ability of cancer screening!
A 🆕 report recommends screening be introduced for lung & prostate cancers and that existing programmes for breast, cervical & colorectal cancer be improved.
👉europa.eu/!RbXFTB
#BreastCancerAwarenessMonth
exalon retweeted
FDA has released a new final guidance for industry on human drug and biological products that contain nanomaterials. bit.ly/3xSuD1Z
exalon retweeted
The International Council for Harmonization issued two draft guidelines that should make it easier for manufacturers to switch analytical methods for testing medicines postapproval. bit.ly/3K1J2fq
exalon retweeted
Did you miss our press briefing on the conclusion of the review of #COVID19Vaccine AstraZeneca and blood clots? You can watch it on EMA’s YouTube channel: youtu.be/qYmP02SIQNI
exalon retweeted
"#Qatar, as part of efforts to achieve self-sufficiency in terms of necessary medicines, is expected to introduce the popular eCTD very soon..." industryhttps://www.thepeninsulaqatar.com/article/31/05/2018/Qatar-to-achieve-self-sufficiency-in-medicine-soon
exalon retweeted
Automation of validation of eCTD and NeeS sequences #Australia #TGA #eCTD tga.gov.au/automation-valida…
exalon retweeted
gulftoday.ae | eCTD to unify registration of pharma products in GCC gulftoday.ae/portal/65e0104d…
exalon retweeted
#FDA Guidance Referencing Approved Drug Products in #ANDA Submissions Jan 2017 fda.gov/downloads/Drugs/Guid…
exalon retweeted
Curious about @HealthCanada's Common Electronic Submissions Gateway #CESG for #Regulatory #eCTD (drug filings)? FAQ: hc-sc.gc.ca/dhp-mps/prodphar…
ALT Health Canada illustration of the High Level Architecture of the Common Electronic Submissions Gateway (CESG) for electronic-courier transactions of Regulatory Affairs submissions. (Source: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/cesg-pcde/faq-eng.php)
exalon retweeted
IDMP: Increasing Delays Mimic PIM? blogs.csc.com/2016/12/29/idm… via @CSC
exalon retweeted
Europe’s drug regulator EMA opens vaults of clinical-trials data - NatureNews
nature.com/news/europe-s-dru…
exalon retweeted
According to Dr Pan, there are 4 years left before entering the era of #bioeconomy. Stay calm and wait... ow.ly/nNEW301wQQj
exalon retweeted
All e-submissions (any regulatory activity) need to be provided via CESP or CD/DVD #eCTD teapawt.net/ectdexperts/status/729…
Lithuanian State Medicines Control Agency (SMCA) request all drug regulatory submissions as eCTD or NeeS (no paper)
vvkt.lt/eng/For-Marketing-Au…
exalon retweeted
Clinical trial accident in France leaves six critical, one “brain dead”. We will provide updates as we get them pharmafile.com/news/502339/c…
exalon retweeted
#EMA Roadmap for #IDMP sco.lt/6Li1Nh Lots of info on EU systems implementation, sponsor dates less clear
exalon retweeted
FDA Update on Grouped Submissions via @GlobalSubmit sco.lt/6ORNNR Low usage - 3 submitted to CDER in 1st 6 months
exalon retweeted
Uncovering #IDMP: The What, Why, When and How Behind the Standards sco.lt/6PgN4T