Achievements:

27th May 2015: Eurodis Membership Meeting Madrid - OACS attended.

 

March 2015: OACS have been approached and we now have a member on the he Patient Group Consultative Forum, part of the MHRA consultation process.

 

March 13th 2015: Valproate Medicines Risks and Benefits - MHRA stakeholder meeting

 

February 27 2015: Karen Keely attended Rare Disease Day, Ireland.  Karen was called up to be presented with flowers. chair of cystic Fibrosis Ireland and the MRCG, in honour of the incredible  work she has done this year, bringing concerns regarding sodium valproate to the forefront in Ireland.

 

January 2015: OACS has hit the ground at great speed for 2015 thanks to Karen/OACS fantastic work with the Sanofi Statement. The Disability Federation of Ireland thanks Karen Keely, OACS Irish Liasion Officer,  for highlighting concerns regarding sodium valproate:

February 24 2015: Deborah Mann, Secretary and Research Co-ordinator attended the Rare but Real  Eurodis Policy Event in Brussels. Deborah attended a meeting with Philip Walsh (CEO at Cystic Fibrosis Association of Ireland and Chairman of the Medical Research Charities Group)

 

January 2015: Nick Sireau began mentoring OACS as part of the Findacure Mentoring Scheme.

 

January 2015: OACS Have important meeting with Officals and Members of Parliament and hope to have some news in the next few months.

December 2014: Karen Keely of OACS Ireland, attended many meetings, that resulted in the outcome of the recent statement from Sanofi,  The question on everyones mind foe 2015, will they release this statement now for the whole of Europe?

 

 

 

13 November 2014: NHS meeting - Deborah Mann from OACS, Susan Cole from Justice for FACS and Emma Friedman for FACSaware attended the NHS meeting in order to consult with patient groups in order to find an effective method of providing information to the patient regarding the effects of sodium valproate.

 

10th October 2014: Light at the end of the tunnel - Medical advice to pregnant women has been wrong for 43 years. After 12 months collaborative work, the European Medicines Agency has completed its review into Sodium Valproate.

27th June 2014: PRAC

The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use. The main responsibility of the PRAC is to prepare recommendations on any questions relating to pharmacovigilance activities related to a medicine for human use and on risk-management systems, including the monitoring of the effectiveness of those risk-management systems. The review of valproate medicines has been requested by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) following the publication of new studies suggesting that in some children problems in development, which can include autism, may be long-lasting. 

The MHRA also noted that there was a need to update the product information of these medicines to bring them in line with current evidence. The European Medicines Agency are now reviewing the available data on the benefits and risks of valproate and related substances and will issue an opinion on the use of these medicines in pregnant women. All those attending have been asked not to share what happened, but we do truly believe that the outcome will be very positive. The next stage in this process will be the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh), will examine questions relating to marketing authorisation of a medicinal product. It will be after this that the EMA will make their final decision.  Attending for OACS are Deborah Mann; OACS secretary, Branwen Mann; trustee and youth representative.

18 June 2014: APPG

OACS attended the Alec Shelbrooke MP, Chair of the APPG Thalidomide and other harmful drugs prescribed during pregnancy, has added Sodium Valproate birth defects to the APPG. The purpose of this meeting was to formulate a workable strategy to raise awareness of FACS.

 

Branwen Mann attemded represented the chldren of FACS. Jo Cozens; chair person of OACS was also in attendance with Karen Keely observing for OACS Ireland North and South, Tim Noakes was there for the Dads and parents: Amanda and Helen Connolly and FACS person: Sophie Holmes also attended. From this meeting the government will be funding a booklet for use within the NHS. Sanofi and the epilepsy society have said that they will update their pregnancy information.

 

29 October 2013: Norman Lamb Meeting

OACS attended a meeting with Norman Lamb MP; Minister of Care and Support with Facsaware, Ian McLachlan (a campaigner from Scotland) travelled from Glasgow. InFact and Facsa were also represented. The intention was to put across the experiences of our children and our fears for their future. Susan Cole and Deborah Mann, attended on behalf of OACS and Emma Friedman, and Branwen Mann from FACSaware. We were shocked to find that governmental awareness stemmed from the epilepsy and pregnancy register. Emma Friedman and Deborah Mann explained the concerns of FACSaware and OACS.

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