DIA Europe 2019

Component Type: Session



Speaker

Human milk collection method, challenges, and lessons learned in a multicenter nutritional study
Amelie Goyer, PhD, PMP

How common are claims on the association between the onset of autism and drug exposure: a systematic review
Lindsay Kadjidja, MSc

Component Type: Session
Level: Intermediate



Chair

Sreemanee Raaj Dorajoo, PhD

Component Type: Session
Level: Intermediate

Digital solutions are already being rolled out in pharma R&D and pharmacovigilance, but the regulatory process remains largely manual and time consuming, with slow adoption of innovative digital approaches. However, new solutions are being developed to facilitate digital transformation in the regulatory environment. The combination of smarter working processes and proper use of innovative technologies will drive efficiencies in regulatory submissions while keeping high standards of quality and compliance. Ultimately this could translate into time and resource savings for marketing authorisations and post-marketing requirements that will revolutionise the regulatory environment. Evidently, there are already tools that provide basic automation support (compilation, publishing and storage/archival of documents). In this session we would like to focus on further gains these tech solutions can bring. We will pick up on some of the technologies such as Robot Process Automation (RPA), Artificial Intelligence (AI) or machine learning that are already to some extent present in the regulatory environment and later expand this discussion into more future approaches as e.g. support for intelligent drafting of key documents, automatic and intelligent compilation of dossiers based on latest regulatory intelligence screenings and the complete dossier processing throughout the life cycle. The interactive component will arise as we will have a session panel made up of regulators, industry experts and academia. These are the three stakeholders that need to jon forces in order to shape the regulatory environment into one that can embrace AI solutions.

Chair

Rob Williams

Component Type: Session



Speaker

Turn Compliance into Value – Decrease Complexity, Increase Compliance and Reduce Total Costs of Ownership
Romuald Braun, MS, MSc, RAC

An Assessment of Real-World Data, Artificial Intelligence, and their Use in Drug Development
Kenneth Hu, PharmD

Text Mining Discharge Summaries of Hospital Electronic Medical Records to Detect Adverse Drug Reactions
Sreemanee Raaj Dorajoo, PhD

Component Type: Session
Level: Intermediate

Drug repurposing is the process of identifying new uses for existing medicines in indications outside the scope of the original approved product information. Drug repurposing constitutes a dynamic field of drug development that can offer real benefits to patients. More and more stakeholders are involved in the debate on how repurposing can be best enabled, including academics, patients groups, the European Commission and the pharmaceutical industry. Local initiatives in some countries such as the UK have started to identify possible frameworks to improve access to repurposed medicines for patients. Using case studies, this session will present in an interactive manner what repurposing can be in practice, and the roles the various stakeholders can play. Attendees will get a better understanding of the key aspects that must be taken into consideration to enable repurposing in ways which benefit patients with medicines supported with robust data.

Chair

Sheuli Porkess, MD, MRCP, FFPM

Component Type: Session
Level: Intermediate



Chair

Leyla Rahjou-Esfandiary, PharmD

Component Type: Session
Level: Basic



Chair

Olaf Schoepke, PhD

Component Type: Session
Level: Intermediate



Learning Objectives

The participants will be able to: - Describe the basic concepts of medical coding and identify its role in modern clinical research and pharmacovigilance. - Identify advantages and distadvantages of applying Artificial Intelligence in medical coding.

Chair

Malin Gunilla Jakobsson, MPharm, RPh