WEBINAR | US INVESTIGATIONAL NEW DRUG (IND) APPLICATIONS

Free webinar on US Investigational New Drug (IND) Applications.

Free webinar on US Investigational New Drug (IND) Applications.
June 18, 2021

SAVE THE DATE!!

Free webinar on US Investigational New Drug (IND) Applications. The experts, Bruce Thompson from WR Regulatory Services, as well as Vicente Tur and Michael Schaub from ASPHALION will discuss about the following:

  • Pre-IND and IND fundamentals; US agent requirements
  • IMPD to IND conversion – going from EU to the US
  • IND eCTD publishing and submission
  • Q&A

📆 When? July 7th, 2021

🕗 Time: 3:00- 4:00 p.m. (CEST)

✑ You can register here:

https://register.gotowebinar.com/register/6371045776036807183

Should you have any questions, you can contact us at: [email protected]

 

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NEWS | Important Update from the FDA!

This guidance recommends steps manufacturers and applicants of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The guidance also describes conditions that may introduce nitrosamine impurities. The unexpected finding of nitrosamine impurities, which are probable or possible human carcinogens, in certain drug products has made clear the need for a risk assessment strategy for the potential presence of nitrosamines in any drug product.

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