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Hi All, No responses to below can anyone help please? Thanks Karen ------------------------------ Karen Real Director Sliema Malta ------------------------------

Hi all, In EU the applicant must have an agreed Pediatric Investigation Plan or  waiver in place before submitting a Marketing Authorisation Application.  Otherwise the application will be refused.  Can anyone please advise if there is a similar requirement in Canada? Thanks in advance for your ...

Photograph: DNA: Copyright: CC. Mark Warner : http://bit.ly/2hV6DXD Dear Colleagues, On 20th October 2017, the EC's Directorate-General for Health and Food Safety  (DG SANTE) and the EMA published a joint action plan to foster the development of advanced therapy medicinal products (ATMPs) with ...

Hi Iris, I too would be interested in getting a consultant in Thailand.  However, one who is very familiar with the submission and process requirments of Clinical Trial approvals in Thailand. Kind regards Karen ------------------------------ Karen Real Director Real Regulatory Ltd London ...

Dear Colleagues, The HPRA in Ireland recently announced that it will support RMS switch free of charge for MAHs which hold a marketing authorisation in Ireland where IE are CMS and UK are RMS.  The HPRA will also provide support to marketing authorisation holders (MAHs) so as to maintain the availability ...