PIPs
Background of ProjectA Paediatric Investigation Plan (PIP) is legally binding and must outline how a company proposes to test the medicine in order to benefit child health and wellbeing. However if there is no known indication for use in children the company may apply for a waiver which must be approved before MAA submission.
Arriello was approached and requested to prepare a series of PIPs for a UK based company. In addition to clinical and non-clinical overviews with GAP analyses, the client needed help planning the needs of all age groups of children, from birth to adolescence for their PIPs.
The Issues
The client did not have in-house solutions to meet this need and was in need of a consultancy with the specific expertise and medics available to help them submit all their PIPs in a timely fashion.
Arriello Solutions
Arriello employs a network of medics with expertise in pharmaceuticals and paedIatric investigation. They are capable of quick turnaround times whilst maintaining the highest level of expertise and analytical approach. Arriello understands that each PIP requires a unique perspective and must be approached and weighted on its merits. Arriello happily provides the CVs of the relevant people working on each project so the client can rest assure that the correct expertise is being allocated to each project.
Furthermore, Arriello is well aware of the format specifications and expectations of EC 2008/C 243/01., EC Regulations Nos. 1901/2006 and 1902/2006. Similarly, Arriello can provide advice on when a PIP waiver or deferral is appropriate. Given all this and its in-house expertise paired with its detailed knowledge and experience with EC guidance, Arriello formed a lasting relationship with the client as their PIPs were submitted.
The Value-Add
- Seamless approach for the client – one project manager
- A Senior Partner of the company was the Project Manager – this meant that weekends and evenings were involved in this project to meet the deadline
- Delivered on time
- Affordable expertise
- Advise on most appropriate route: PIP, Waiver or Deferral
Aktuelle News
05.04.2012 Arriello successfully tests EV WEBTrader
Arriello’s EU QPPV Jiri Sikac, attended a seminar last Friday in which it was announced that A
Weiterlesen...
