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Pdf - Regulatory Strategy

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Europe vs USA: new drug product approvals in 2017

What are the key differences in new drug product approvals across the US and EU regions? Learn about the state of drug approvals in the world's two largest markets.

| Articles, Community News, Homepage News, Library News, News, Services News, Social News

Join us on a 3 day Course, learn about the Development of Biological Drugs

On the 28th - 30th May, NDA will contribute to a 3 day Course in the Development of Biological Drugs in Stockholm and/or distance.

| Community News, Library News, News, Services News, Social News

Meet NDA at DIA Europe 2018

Don’t miss the opportunity to meet our Experts who will present on a number of critical drug development topics and be on hand to answer your questions.

| Community News, Library News, News, Social News

Advanced Workshop in QPPV Toolbox – Your Key to Success

Shelley Gandhi to conduct an Advanced Workshop in QPPV Toolbox – Your Key to Success – in conjunction with DIA Learning on the 12-13 March in Berlin.

| News, Pharmacovigilance

Common failures in drug development

Dr. Lönngren will present and discuss the common failures in drug development from a regulatory and market access perspective and how to avoid these failures.

| Community News, Health Technology Assessment, Library News, News, Services News

Dr. Lönngren presents on hot topics at ARCS Executive Round Table

Dr. Lönngren will address hot topics such as Brexit, expedited pathways, use of RWE in decision making, cost effectiveness and affordability.

| Community News, News, Services News

Meet us at the Phacilitate Cell & Gene Therapy World 2018

NDAs Dr Paula Salmikangas will be moderating a 1-hour ‘Working Lunch’ Panel Discussion on “Safety aspects of genetically modified cells”.

| Community News, Library News, News, Services News

Free Webinar - Development of Cell based Cancer Immunotherapy products

Join us on 8th February to learn how to maximise safety and efficacy of novel cell-based cancer treatments.

| Community News, Library News, News, Services News

Shelley Gandhi Chairs the 2nd Annual Biosimilars Europe Congress

The conference will bring together industry experts to explore the strategies to gain insight into new biosimilar development strategies.

| Biologics, Library News, Pharmacovigilance, Regulatory Affairs, Services News

Join us at Europe CEO, Four Seasons, London

Dr. Thomas Lönngren, Strategic Advisor NDA Group, has been invited to speak in the session 'Regulatory Hurdles: Access Across Borders' at the Europe CEO conference.

| Community News, Library News, News

Free Webinar - The End Game: Payer Engagement

Join us on 30th November to get insight into the HOW to avoid market delays that impact patients and ultimately reimbursement.

| Health Technology Assessment, Library News, News, Services News

Meet us at PEGS Europe

If you are planning to attend this year’s PEGS Europe in Lisbon, we would really like to meet up with you.

| Library News, News, Services News

Regulatory development and alignment between the USA and Europe

NDAs Dr Lönngren has been invited to present on Regulatory development and alignment between the USA and Europe at the EMAP event 24th-26th October London.

| Community News, Health Technology Assessment, Library News, News, Services News

NDA presents at the DIA Value, Access & Regulatory Strategy Workshop

NDAs Professor Pavlovic is on the programme committee as well as chairing session 3 'Early dialog between regulators and HTA'. Professor Silva Lima will present in session 4 'Patient's role in the regulatory and HTA process'.

| Community News, News, Services News

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