We would love to connect with you during the DIA and discuss how we can support you to optimise your path to market approval.
Working together we can:
- Accelerate your drug development program to reduce your time to approval
- Optimise the management of the regulatory process to provide accurate and predictable outcomes
- Reduce your risks and increase the probability of gaining Market Authorization
Don’t miss our great speakers sharing their knowledge in different forums throughout the conference:
Brian Edwards – Principal Consultant
Wednesday, July 1st, Oral Poster Presentation -#CHR 102: Skills, Communication and information in Pharmacovigilance – Oral Poster Presentations
Dr Mira Pavlovic – HTA Expert, NDA Regulatory Advisory Board member
Tuesday, June 30th, 13:00 – 14:00, Session title:#S0407 L: Drug Assessment for Regulatory and HTA Purposes: Similarities and Differences, the Way Forward. Track:04: Value-Access.
This session will explain similarities & differences about regulatory and HTA requirements to support product authorization and access to market, as well as the concept of added therapeutic benefit both from regulatory and HTA points of view.
Prof. Beatriz Silva Lima – Non Clinical Expert, NDA Regulatory Advisory Board member
Wednesday, July 1st, 18:00 – 19:15, Session title:#DL04 SL: Industry – Regulator Dialogue: Tailor-made Regulatory Guidance for Non-clinical to Clinical Development. Track:01: Clinical Trials.
i) First in human programs
Since the implementation of the new revised EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products, there has been an interest as to the response by the Pharmaceutical Industry. Would the guideline be interpreted as too conservative and force companies to conduct FIH studies in non-EU geographies? EFPIA conducted a survey among 12 member companies with 54 FIH studies.
ii) Programs in Severe Diseases/Conditions
For a small number of severely debilitating or life-threatening (SDLT) diseases/conditions, regional guidance’s exist encouraging the use of “ICH S9-like” approaches. A lack of incentives for drug developers to engage into costly development may lead to unclear prospective. This session item will address a harmonized and focused approach on development options for SDLT indications to reduce resources to start early clinical development, to bring innovative medicines to patients faster.
Panellist: How has the New EU Guideline Changed the Conduct of First in Human Trials in Europe
Speaker: Beatriz Silva Lima, NDA Group, Advisory Services
Click here to download the Preliminary Programme.
Pre-book a meeting with one our team, via the DIA App or simply
contact us firstname.lastname@example.org