Thomas Lönngren, Strategy Advisor at NDA Group, has been elected as the 2013 IPS Medal Winner on behalf of the Executive Committee of the Industrial Pharmacy Section of FIP.
Announced on 4th September at the IPS Business meeting in Dublin, the medal was presented by its Chair, Linda Hakes.
Following the award, Thomas gave a presentation on his experience gained from working at the European Medicines Agency and his thoughts on the future.
Dr. Markku Toivonen, Scientific Director at NDA Group, held a talk at this year’s EURORDIS Summer School on Medical Research and Clinical Trial Methodology. EURORDIS is committed to empowering people living with rare diseases and set up its annual Summer School to provide training and hands-on experience on clinical trials, drug development and the EU regulatory processes. Around 40 participants took part, selected dependent on their English language skills, experience in rare disease advocacy, and their willingness to be involved in drug development and regulatory affairs at the European level.
During Markku’s session on clinical research, he discussed the need for greater evidence-based medicine, the lifecycle of drug development from pre-clinical (specifically of orphan medicinal products) and the stages of drug development. After, Markku followed with a session on clinical trials, specifically looking at the ‘Gold Standards’.
This year’s school was held between 17-21 June 2013 in Barcelona. For more information, please see: http://www.eurordis.org/content/eurordis-summer-school-patient-advocates.
Dr. Panos Tsintis, a member of NDA’s Regulatory Advisory Board, was shortlisted for a Lifetime Achievement Award at the TOPRA Awards 2012. The award recognises an individual who through his or her life’s endeavours has demonstrated a significant and lasting contribution to Regulatory Affairs – over and above what might have been expected from the professional role the individual was employed to do.
Dr. Panos Tsintis has spent over 20 years working in regulatory affairs and pharmaceutical medicine, across industry, consultancy and with a substantial contribution within EU regulators, from drug development to post-marketing. Today, Panos provides strategic advice to a number of international pharmaceutical companies – including risk management, regulatory support in MAA and orphan drug designation, paediatric plans, through to scientific advice and crisis management.
In this article, published in the February 2013 issue of Regulatory Affairs, Markku Toivonen discusses the need to consider the elderly in global drug development. The reasons for the mis-prescribing in this fast growing population are discussed, highlighting the importance of adequate representation in clinical trials, pre and post authorisations studies. Shortcomings in current regulatory guidance, recruitment problems and lack of specific information for older people are cited among the myriad of factors that need to be redressed. Markku discusses the way forward and steps that regulatory bodies are taking to address these challenges.
You can find the article here.
Dr Markku Toivonen MD, PhD.
Scientific Director, NDA Group.
Within the framework of SNS, Centre for Business and Policy Studies, and the research project Value of new drugs, a number of researchers at the SNS initiative examined a number of issues of great importance for health care. The final report presents overall conclusions and policy suggestions for how we can improve today’s decisions on the use of drugs, both for the drugs that are available today and the new drugs coming on the market.
Authors are NDA’s HTA Advisory Board Chairman Bengt Jönsson and Katarina Steen Carlsson. The report was presented at a conference in Stockholm 22 November and was discussed by leading decision makers in the Swedish health-care and pharmaceutical policy, for example Christina Åkerman Director General of the MPA and Anders Blanck CEO LIF, the Swedish life science industry organisation. NDA’s Thomas Lönngren who also contributed to the report participated in a couple of the panel discussions as well.
You can read the report here.
Professor Bengt Jönsson
Professor in Health Economics at Stockholm School of Economics. Founding director of the Centre for Health Technology Assessment (CMT) at Linköping University. Member of the Editorial Board of the European Journal of Health Economics and the International Journal of Health Technology Assessment in Health Care.
Former President of the international Health Economics Association. Advisor and consultant to WHO, OECD and the World Bank.
The company approached NDA as it had no expertise or experience of paediatric requirements in Europe. Before the company could submit the MAA, it was necessary for a PIP (Paediatric Investigation Plan) to be approved.
Shelley Gandhi, NDA’s Head of Pharmacovigilance services, has been invited by the United Arab Emirates government to speak at their 3rd National Pharmacovigilance & Risk Management Conference on 29th and 30 May, titled: “New Pharmacovigilance Legislation, Implementation and Risk Management Assessment Industrial Perspective”. The main objective of the conference was to inform the pharmaceutical companies to report ADR and submit their PSUR to the national authority in UAE in order to minimise medication error and adverse drug reactions. Shelley spoke on a number of topics, including ICSRs & MedDRA, Signal Detection and Management, PSUR (PBRERs) and co-chaired shared panel sessions, to an audience that included physicians, pharmacists and Pharmacovigilance officials and specialists.