We are already in Quarter 2 of 2016 and as it comes to the end of April we thought it necessary to update current and potential clients as to where we will be and where you can meet us in 2016.
As a company providing expert advice and support to our clients we at Ivowen feel it is very important to actively seek out new regulatory information, to equip ourselves with knowledge on what is ‘coming down the line;’ keep abreast of industry and legal developments, and, to remain ahead of the game with regard to regulatory updates and new proposals. Conferences and continuing professional development is an integral part to providing our clients with the best service.
At present we will attend the following conferences/workshops; please feel free to say ‘hi’ and ask any questions; we always welcome opportunities to meet with current and potential clients and build relationships.
Venue: Sheraton Hotel Athlone, IRELAND
Information: HPRA 2016 Safety Workshop
This workshop is aimed at the implementation of safety features on outer packaging of specified medicines for human use.
The EU Falsified Medicines Directive (FMD) 2011/62/EU, introduces the requirement for manufacturers / Marketing Authorisation Holders (MAHs) to add safety features (that include an unique identifier) to the outer packaging of specified medicines for human use and to fund an Europe-wide verification system which will enable the authentication of medicines before the unique identifier is decommissioned and the pack is dispensed to a patient. The mandatory implementation of the regulation must be completed no later than 3 years from its publication, i.e. by the 9th February 2019. Updates on this course to follow soon – watch this space!
Venue: Hotel Slon, Ljubljana, SLOVENIA.
Information: 14th annual EuDRAcon conference
We will be attending the 14th EuDRAcon conference in Slovenia. EuDRAcon is an abbreviation for European Drug Regulatory Affairs Consultants. It is a pan-European network of regulatory affairs consultancy companies dealing with drugs, medical devices, cosmetics and food supplements. The conference this year will be hosted by MediSanus d.o.o.
Venue: Medicines Evaluation Board, The NETHERLANDS
Information: 13th Annual TOPRA symposium
The 13th annual symposium for TOPRA is being held in Amsterdam this year. This symposium cover topics such as public health needs, update on legislation for orphan drugs, paediatrics and pharmacovigilance, clinical trial regulation, drug-device combination products, regulatory science etc. More information is available at: https://www.toprasymposium.org/ . We shall be attending the conference in its entirety.
Venue: Fira de Barcelona Gran Via, Barcelona, SPAIN
Information: CPhI Worlwide exhibition
CPhI worldwide exhibition offers the opportunity to ‘keep abreast of the latest industry developments: stay up-to-date on market news and trends during the Pre-Connect Conference, CPhI Pharma Innovation Award, free sessions in Exhibitor Showcases (Previously Speakers’ Corner), Free Content – Pharma Insight Briefings.’ This exhibition also offers the chance to connect with companies and people in the pharmaceutical industry from around the world. More information is available here: http://www.cphi.com/europe/
During the year we may also be attending other conference/events/training, please get in touch if you would like to meet us at an event; or if you or your team require training in any aspect of EU legislation or MRP/DCP/CP and CTD systems for registering generic drugs in the EU, which is our speciality.
If you have any queries on the above, would like to organise a meeting, or if you have any other queries please contact us . If you see us at any of the events please do come and say ‘hello.’ We are looking forward to meeting everyone.