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Vacature Medical Affairs Consultant
We are looking to expand our team with a Medical Affairs colleague who has the ambition and potential to grow in our organization. All projects within IN2Pharma are worked on in small teams of 2-5 people and for some projects, you also work on site at the clients’...
Maximum levels of citrinin in food supplements based on rice fermented with red yeast Monascus purpureus published
Europe A new Commission Regulation has been published ((EU) 2019/1901) amending Regulation (EC) No 1881/2006 regarding maximum levels of citrinin in food supplements based on rice fermented with red yeast Monascus Purpureus. The maximum level of citrinin has been set...
Change of consultation procedures related to the implementation of the Medical Device Regulation
The Netherlands Starting from 26 May 2020 the ‘College ter Beoordeling van Geneesmiddelen (CBG)’ will be giving advice according to the new Medical Device Regulation (MDR, EU 2017/745). Starting from 1 December 2019, the CBG only handles requests for consultation...
New nomenclature for incidents with medical devices
Belgium From January 2020 there is a new nomenclature applicable for manufacturers reporting an incident with a medical device to the FAMHP. The FAMHP advises manufacturers of medical devices to already change their internal codes to the new nomenclature codes. The...
Nitrosamines in medicinal products: report results of risk assessments for impurities
Belgium As a precaution, the European Medicines Agency (EMA) and European medicines authorities asked marketing authorisation holders in October 2019 to perform a risk assessment on the presence of nitrosamines. The Federal Agency for Medicines and Health Products...
Public consultations on labeling and naming policy
The Netherlands The Medicines Evaluation Board (MEB) invites interested parties and stakeholders to comment on 2 amended policy documents on the labeling of medicines for humans (MEB 6) and the naming of pharmaceutical products (MEB 13). The most important changes are...
Information session about PharmaStatus
Belgium Via the new online application ‘FarmaStatus’, marketing authorization holders can notify the FAMHP of unavailability and start or stop of commercialization of a medicinal product. Marketing authorization holders are invited to an information session on...
Steps to take to avoid nitrosamines in human medicines
Europe EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorization holders (MAHs) for human medicines containing chemically synthesized active substances review their medicines for the possible presence of nitrosamines...
Falsified Medicines Directive: end of transition period and beginning of monitoring activities
Belgium From 9 February 2019, all prescription and reimbursable medicines on the market must bear safety features. At each link in the distribution chain, the safety features must be checked so that the authenticity of the medicine upon delivery can be guaranteed....
GMP and GDP certificates no longer on paper
Belgium Certificates for Good Manufacturing Practice or Good Distribution Practice can be queried in the EudraGMDP database. The FAMHP will no longer automatically provide paper versions of these certificates, only upon request via this request procedure. Source:...
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Vacature Medical Affairs Consultant
As a Medical Affairs Consultant, you will support the Qualified Person Responsible for Information and Publicity (QP RIP) in in establishing compliant promotional activities and materials for multiple pharmaceutical and healthcare companies in Benelux and contribute in medical writing projects …
Junior Consultant Job Vacancy
As a junior consultant at IN2Pharma, you will be trained to support more senior colleagues in ensuring the client’s products meet the required standards of quality and safety and in ensuring regulatory compliance for a defined range of products of the client’s portfolio. This gives you the opportunity to acquire experience within one or several of the following domains …
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