The European QP Association is quite active in supporting its members. What has been achieved in 2018 so far?
Comments of the EQPA Board on the Revision of 'Annex 1: Manufacture of Sterile Medicinal Products' were submitted to EMA in early March.
The European Medicines Agency (EMA) issued the draft of the Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice. The public consultation started end of May. The IMP Working Group of the European QP Association plans on submitting consolidated comments, and asked EQPA members for feedback.
EMA has updated their template for GMP non-compliance statements for manufacturers after inspections. One major driver was the intent to provide clarity and support in such matter to the QPs. A survey was performed to evaluate the QPs' expectations and needs. Altogether 77 colleagues provided their feedback. The results are submitted to EMA.
The European Medicines Agency (EMA) asked industry associations throughout Europe to pass on some questions to their members to receive feedback with regard to the qualification of API manufacturers. The European QP Association therefore compiled a questionnaire for its members. The survey was conducted in January 2018. Altogether 245 members provided feedback. The results were summarised and sent to EMA and published in the EQPA website's member' area.
Survey on Direct to Patient Shipments: Based on the evaluation forms of the IMP pre-Forum session, the presentation on On-demand packaging and Direct to Patient (D2P) shipments was well received and appreciated. Therefore the IMP Working Group invited the members to complete a survey on D2P shipments.
The IMP Working Group has met in Brussels to discuss the programme for the QP Forum and a meeting with EFPIA to discuss the Clinical Trial Regulation with respect to "labelling challenges" (Annex VI). Niina Taylor represented the EQPA's IMP Working Group at EFPIA's CTR - Annex VI Interested Parties Focus Workshop on 2nd of July 2018 at UCB's site in Brussels
The programme of the 13th QP Forum has been finalised and placed on the market. More than 25 speakers have accepted an invitation and are listed on the programme. Amongst them are six speakers from authorities, inspectorates and societies.