NDA Group

Steffen Thirstrup is suggesting that we do not wait for a revolution in CNS but instead look to the iterative improvements that have been characterising oncology development over the last years. @NLSDays

If you are planning to attend this year’s NLS days, we would really like to meet up with you. Book a meeting now to discuss how a tailored global drug development strategy can maximize your product´s potential value and accelerate time to drug approval. [email protected]

There is still a chance to book your place at our popular lunch seminar in Cambridge bit.ly/2WcyksR #regulatory #seminar #trials

Sign up now for our July seminar in Munich. bit.ly/2KBdkdV #regulatoryaffairs #munich #seminar

Steffen Thirstrup: "As always a fantastic experience teaching a short course at #DIA2019 together with Lisa Peluso. Great audience, so much fun!" Now our workshops are finished - but you can still contact our experts to book a meeting! [email protected]

Our advance team has arrived at #DIA2019 and our first workshop is underway! #workshop #regulatoryaffairs #whatwedo

NDA's Pharmacovigilance & Drug Safety expert Brian. Edwards is heading to DIA San Diego, where he has been asked to speak on three different panels. Don't miss the opportunity to ask your questions to Brian while you are there. #pharmacovigilance #DIA2019

Thought Leadership "The most critical meetings are those where the scientific committees of the EMA would like to question the sponsor to fully understand the data and the sponsor’s position." Steffen Thirstrup bit.ly/2WZO5nw #regulatoryaffairs #Oralexplanations

This week the EMA announced that they will be reinstating a number of activities that had been put on hold due to the Brexit. lnkd.in/dmBS8xe #regulatoryaffairs

Read Lisa Peluso’s whitepaper, Importance of Excellence in Scientific and Regulatory Communication and learn more about how you can avoid costly delays along the path to regulatory approval. bit.ly/31BZ225 #regulatoryaffairs #Oralexplanations #Advisorycommittee

You still have the possibility to sign up for NDA's seminar on 2 July 12:00-14:00 in Cambridge, UK, where Dr Niamh Kinsella is talking about Navigating the Regulatory Maze - Initiating Your Phase 1 Trials. bit.ly/2WcyksR

Are you attending DIA San Diego? If so keep an eye out for our experts Lisa Peluso and Steffen Thirstrup who are presenting our popular short course: European Regulatory meetings: How Best to Prepare & Perform: bit.ly/2XgOV3j

If you are attending the DIA in San Diego we'd love to meet you. Book a meeting with one of our experts now: [email protected] bit.ly/2WPhohr #DIA2019

Welcome to NDA's seminar on 2 July 12:00-14:00 in Cambridge, UK, where Dr Niamh Kinsella is talking about Navigating the Regulatory Maze - Initiating Your Phase 1 Trials. More information and registration: bit.ly/2WcyksR #seminar #regulatory #trials

Regulations are complicated as is drug development. Ultimately its actually really simple - Together we bring medicines to those who need them wherever they are in the world. youtube.com/watch?v=vK83GB3T… #marketaccess #regulatoryaffairs #drugdevelopment #patientsfirst

Solve your most difficult regulatory challenge at BIO. Meet Dr. Laurie Smaldone Alsup MD for a chat about how to resolve the issues that could cost you time, money and potentially approval. lnkd.in/gaEFjuY #regulatory #bio2019

This report recently released by ICMRA discusses how various regulators worldwide are working together to better identify and address future regulatory challenges posed by new categories of therapeutics. lnkd.in/dUdSDW3

This is a brilliant initiative and we are very proud that NDA's Stephanie Krumholz has been asked to participate as one of the trainers supporting this project. lnkd.in/dcAiTCF #regulatoryaffairs

Steffen Thirstrup has been busy this week representing us at a seminar in Stockholm and speaking at the Topra event in London yesterday. Soon he will be jetting off to San Diego to present a short course at the DIA. Click here for more information sched.co/Kfay

Thank you to everyone who attended our seminar yesterday, we hope you all enjoyed it as much as we did! If you missed the seminar on the topic: Optimising Value - Regulatory and Market access considerations, please contact us at [email protected] #HTA #Marketaccess