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So far efpiamapps has created 16 blog entries.

“Using registries in real world evidence: Paving the path for success” by Emma Du four and Chris Chinn

October 2106 – By Emma Du Four, Senior Director Regulatory Policy & Intelligence at AbbVie and Chris Chinn, Head of Real World Investigations, SanofiOn 28 October 2016, the European Medicines Agency (EMA) will hold the EMA registries workshop regarding the use of registries in real world evidence. In advance of this discussion, Emma Du Four, […]

By |October 4th, 2016|News|0 Comments

“Pre and post licensing should not be two different lives, it’s one continuous life”: A Report From The DIA 2016 Session ”Europe and the US: Making Outcomes-Based Health Care Possible”

On 29 June 2016, key stakeholders and decision-makers in the field of real-world evidence met to take part in the DIA 2016 seminar “Europe and the US: Making Outcomes-Based Health Care Possible”. As Europe and the US continue to examine ways to develop therapies on the basis of their “real world” performances, the session aimed […]

By |August 29th, 2016|Uncategorized|0 Comments

Luk Maes Reports on DIA Hamburg’s “MAPPs: The IMI ADAPT SMART Project”: Views from Payers, Consumers and HTA Bodies

June 2016 – by Luk Maes

This April, thought leaders in the field of adaptive pathways met at the DIA EuroMeeting 2016 in Hamburg to discuss the progress made in MAPPs (“Medicines Adaptive Pathways to Patients”) —as well as the challenges still ahead. Co-chairing the panel “MAPPs: The IMI ADAPT SMART Project” was Luk Maes, Executive Director Scientific Policies […]

By |June 21st, 2016|Uncategorized|0 Comments

“Advances in science and technology are there—It’s up to us to keep up with them”: An Editorial From Sarah Garner of NICE

June 2016 – by Sarah Garner

As the keynote speaker in the EMIF Conferences, E-managing the Future of Health Data, Dr Sarah Garner spoke on a number of initiatives making use of real world evidence—specifically highlighting the significance in RWE in furthering the conversation on MAPPs. Here, she reflects on how the opportunities changes in technology allow us […]

By |June 21st, 2016|News|0 Comments

EMA’s PRIME can help speed delivery of new medicines to patients – by Susan Forda

1st March 2016 – by Susan Forda

Last week, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted the Priority Medicines (PRIME) scheme. PRIME is a welcome step towards connecting healthcare decision-makers to expedite patient access to new medicines – but what sets it apart from other mechanisms with similar aims? The […]

By |March 1st, 2016|News|0 Comments

Susan Forda, BPharm, MSc, PhD, MRPhS

Vice President, International Regulatory Affairs Eli Lilly and Company

Sue trained as a pharmacist. After completing a PhD in neuropharmacology, she worked as a post-doctoral research fellow at St George’s Hospital Medical School, University of London. She later joined Beecham, subsequently SmithKline Beecham Pharmaceuticals, as a regulatory associate in their Worldwide Regulatory Affairs Department. Over a […]

By |March 1st, 2016|Uncategorized|0 Comments

About Marshall L. Summar

Chief, Division of Genetics and Metabolism
Vice-Chair, Special Projects
Magaret O’Malley Chair of Genetic Medicine, Chair of the Scientific and Medical Advisory Committee of the National Organization for Rare Disorders (NORD®)

 

 

 

 

 

Marshall L. Summar, MD, is Chief of the Division of Genetics and Metabolism at Children’s National Health System. He leads the largest clinical division of its kind in the […]

By |January 20th, 2016|Uncategorized|0 Comments

Interview with Marshall L. Summar: MAPPs in the Rare Disease Space

March 21st – by Alison Kilian

 

 

 

 

 

When it comes to rare diseases, it’s important to find the fastest path and look beyond traditional trial models to meet patients’ needs, says Marshall L. Summar, MD, co-chair of the rare disease advisory panel of Patient-Centered Outcomes Research Institute (PCORI) and the Scientific Advisory Committee of the National Organization […]

By |January 20th, 2016|Uncategorized|0 Comments

Event Report and Video: New Paths to Personalised Medicine – A Live Webstream from the European Health Forum Gastein

On 30th September, thought leaders in the field of personalised medicine from Europe, the United Kingdom and the United States met in Bad Gastein, Austria to discuss how Medicine’s Adaptive Pathways to Patients (MAPPs) and breakthrough designation will impact patients. In a moderated discussion with the experts, the audience and live participation from the public […]

By |October 5th, 2015|News|0 Comments

Interview with Sabine Atzor: Examining the Building Blocks of MAPPs

September 30th – by Alison Kilian

 

 

 

 

 

 

 

To truly understand Medicines Adaptive Pathways to Patients (MAPPs) from a regulatory perspective, it’s essential that we take a closer look at the building blocks – both old and new – that are paving the way for its implementation, says Sabine Atzor, Director Regulatory Affairs, part-time seconded from F.Hoffmann-La Roche […]

By |October 1st, 2015|News|0 Comments