Contribuiamo al successo delle aziende di Dispositivi Medici e Diagnostici in Vitro negli Stati Uniti ed in Europa
Siamo esperti riconosciuti nella gestione di studi clinici su Dispositivi Medici, IVD e Combination Products in Europa, Stati Uniti e Canada.
Da oltre 20 anni Donawa Lifescience Consulting (DLC) offre consulenza regolatoria specializzata
ed altamente qualificata nel settore dei Dispositivi Medici, inclusi i Combination Products
e gli ATMPs (Advanced-therapy medicinal products). DLC può
agire inoltre come mandatario europeo (Authorized Representative) per fabbricanti con sede legale extra europea.
Diagnostici in Vitro
Diagnostici in Vitro
Da oltre 20 anni Donawa Lifescience Consulting (DLC) offre consulenza regolatoria
specializzata ed altamente qualificata nel settore Dispositivi Medici,
inclusi i Diagnostici in Vitro (IVD). DLC può agire inoltre come
mandatario europeo (Authorized Representative) per fabbricanti con sede
legale extra europea.
Esistono molte differenze tra le normative europee e statunitensi sui
Combination Products e i dispositivi drug-delivery. Donawa Lifescience
Consulting ( DLC ) puo fornire consulenza strategica per identificare
tali differenze così da permettere il raggiungimento delle varie
tappe dello sviluppo del prodotto nel rispetto dei tempi previsti.
19 cities vie for EMA after Brexit
4 August 2017
The European Commission has received 19 offers from European cities to host the European Medicines Agency's (EMA) headquarters as it moves from London's Canary Wharf following Britain's decision to leave the EU. A final decision on the new location will be taken at the General Affairs Council and announced on 20 November 2017. The cities that have applied to host the EMA as of 1 August 2017 are:
The Commission's assessment will be based on six criteria agreed to by the 27 member states, including operationality guarantees (the availability of appropriate offices), location accessibility (which includes the frequency and duration of flight connections), schools for EMA staffers' children (including the availability of multi-lingual schools), access to the labour market and health care for staffers' families, business continuity (to maintain and attract highly qualified staff) and geographical spread.
EMA publishes its plan for post-Brexit
4 August 2017
The European Medicines Agency (EMA) has developed and initiated a business continuity plan to deal with the uncertainty and workload implications linked to the United Kingdom’s (UK’s) withdrawal from the European Union (EU) ('Brexit') and the Agency’s relocation from London to an as yet unknown destination, according to a press release dated 1 August 2017.
“Preparing for the move, managing the necessary changes, and addressing challenges such as possible losses in skilled and experienced staff, in a proactive and efficient way requires considerable internal resources,” said Noel Wathion, EMA’s Deputy Executive Director and head of EMA’s Brexit task force. "With the business continuity plan we aim to ensure that the assessment of medicines is not disrupted and that patients in Europe continue to have access to high quality, safe and effective medicines.”
The business continuity plan is a tool that will help EMA take the difficult decision to reallocate the available resources as needed to maintain its priority activities over the next years. It categorises and prioritises tasks and activities according to their impact on public health and the Agency’s ability to function. The plan sets out three layers of priority.
In May, EMA started to scale back activities in the outer layer, so-called category 3 activities, to free up 43 staff by the end of 2017 who are focusing on the preparations for the UK’s withdrawal from the EU and EMA’s relocation. To achieve this, the Agency decided to temporarily suspend a number of lower priority activities.
Category 2 activities will be maintained for as long as possible, workload and staffing situation permitting, in order to maintain the development of new medicines. These include the proactive publication of clinical data, and various initiatives aimed at promoting availability of medicines, as well as some political priorities of the EU, for example, EMA’s contribution to the fight against antimicrobial resistance or the Agency’s interactions with Health Technology Assessment (HTA) bodies.
Category 1 includes the highest priority activities that are either directly related to the assessment and safety monitoring of medicines or vital to maintaining the infrastructure of the European regulatory system for medicines, including the coordination of actions to protect the safety of patients in all EU Member States, inspections across the EU or maintenance of the functionality and security of critical IT applications used by all Member States. EMA comments that it is absolutely crucial to uphold these activities, as any disruption would almost immediately have a detrimental effect on the health and well-being of citizens in Europe, and would also jeopardise production and distribution of medicines in the EU.
Further iterations of the business continuity plan will also take into account various scenarios for staff losses and how these may affect the delivery of category 1 and 2 activities. Unexpected higher, faster or more permanent loss of staff as a consequence of the Agency’s relocation may lead to a situation in which EMA’s operations can no longer be maintained. EMA advises it will provide further updates on the implementation of its business continuity plan as necessary.
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