NDA Sweden hosted a breakfast seminar the 15th May on the ‘Current and future changes to the European pharmaceutical industry´.
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Professor Beatriz Silva Lima, PharmD, PhD, Non-Clinical Expert for NDA's Regulatory Advisory Board, spoke last week in Vienna, Austria at the European Interdisciplinary Summit on Cell Based ATMPs on the subject of 'State of the Art Safety Testing of Cell Based ATMPs.
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Avril Mankel, one of NDAs Senior Regulatory Affairs Managers, was recently course leader and speaker at the EUCRAF Seminar 5 in Germany titled "Specific Considerations for the Development and Authorisation of Medicinal Products for Children".
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Dr. G Narayanan (MD, MRCP (UK), FRCP, FFPM) has joined the NDA Group. Formerly an Expert Medical Assessor within the biologics and biotechnology unit for the MHRA in the UK, Narayanan brings over 15 years’ combined experience within the industry and agency, coupled with extensive clinical expertise and knowledge.
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The new Good Distribution Practice (GDP) guideline has arrived and NDA is helping you meet the challenges with several services to ensure you're on top of the changing requirements.
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The March 2013 volume of the journal “Bioanalysis” features a review article authored by Paul Chamberlain, NDA Regulatory Advisory Board, which considers the reasons why it is not possible to pre-define an acceptable margin of difference in anti-drug antibody incidence or magnitude for the classification of biosimilarity of therapeutic monoclonal antibodies. The article discusses how a “totality of evidence” approach could be applied to define differences in immunogenicity that are clinically meaningful. Paul Chamberlain will also present on this topic at the forthcoming “Biosimilar
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During two days in March NDA hosted the CIOMS Working Group IX's meeting: Practical Considerations for Development and Application of a Toolkit for Medicinal Product Risk Management. CIOMS representatives from across Europe, Japan and Australia, amongst other countries, attended the meeting. In all there were 17 participants.
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Dr Brian Edwards will be presenting and chairing at several events over the next few months on the latest developments relating to pharmacovigilance, outsourcing and clinical research.
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In this article, published in the February issue of SCRIP Regulatory Affairs, Markku Tiovonen 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
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In this commentary, published in MedNous’ January issue, NDA’s CEO Johan Strömquist discusses implications of the new Pharmacovigilance legislation in Europe on the management of pharmaceutical companies.
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Rosalind Cox, Scientific Advisory at NDA Group, writes an article for the December issue of Regulatory Rapporteur on the new EU Medical Device Legislation. She reviews the key impacts of the proposed legislation, referencing that they are still up for review before gaining EU Parliament agreement.
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On November 22th NDA Sweden hosted a breakfast seminar on the topic “new pharmacovigilance legislation in Europa”.
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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.
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In this article, published in Regulatory Rapporteur, September 2012, Thomas Lonngren, strategic advisor to NDA Group reflects on the hurdles to overcome and roadblocks still to be negotiated in Drug development – particularly in measuring the “value” of new medicinal product.
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In this commentary, that is published in MedNous May 2012, NDA's Brian Edwards explains what companies need to know about new EU legislation.
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In this commentary, that formed the basis for articles in MedNous as well as Scrip RA, NDA's Johan Strömquist discusses the situation facing industry, regulators and health technology assessors on their road to achieve the ultimate objective: Getting good medicines to patients.
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As the date for the introduction of the new pharmacovigilance package is drawing nearer, the EMA is releasing more information on the new regulation. However, in January 2012, responding to industry concerns a decision was taken to considerably reduce the information to be submitted to Eudravigilance by the time of introduction of the new regulations. In this article NDA’s Barbara Jones describes the changes.
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Following the succesful delivery of top level regulatory advice since 2002, NDA is now complementing its Regulatory Advisory Board with the addition of the NDA HTA Advisory Board. The new addition allows NDA to provide a unique advisory service, combining Europe's top level regulatory and HTA expertise to deliver joint advice.
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This article, written by NDAs Jill Challis, reviews the impact of the Regulation over the last five years on improving the likelihood for safer and more effective use of existing medicines in children.
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Wasting $60 billion on failed drug development programmes is unacceptable. But just how does the industry improve its strategy in getting new drugs to market quicker? NDA's Dr Lars-Helge Strömquist, comments on the state of the industry.
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Pharmaceutical companies have many factors to consider in deciding whether a switch to over the counter is the right strategy for their products. NDA's Rosalind Cox recommends a structured approach.
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