The two-day event was organised in collaboration with Clariant and Sanofi and offered key industry presentations to the participants.
Day 1 - Focus on regulations, REACH, IPAC-RS and MedPharmPlast Europe's activities
MedPharmPlast Europe President Steve Duckworth (Clariant) moderated the event on both days. On Tuesday, Christian Pommereau from Sanofi welcomed all participants and introduced Sanofi to them.
From the MPPE member Nelson Labs, Frank De Smedt gave an update on the changes to USP, EP and ISO.
As there are several uncertainties regarding the Medical Device Regulation, four presentations of the conference (two each day) were dedicated to the topic.
As MPPE is involved in the Medical Device Coordination Group, Patrick De Kort gave an update on behalf of Pascale Van Hoydonck (Terumo) with insights regarding the required Commission EU MDR technical guidance. Nathalie Bujis from Medtech Europe presented about the implementation of the MDR requirements on CMR & endocrine disrupting substances. Nathalie also gave an interesting second presentation about the issues of the REACH restriction proposal on microplastics in the medical technology sector.
Afterwards, the audience heard how SABIC differentiates its engineering resins with extractable and leachable data from Hans De Brouwer and an update from Gaby Reckzügel (Boehringer Ingelheim Pharma) about the baseline requirements for materials in contact with drug products – recommended by IPAC-RS.
Before the first day of the conference ended, Steve Duckworth MPPE President presented the goals and activities of MedPharmPlast Europe (MPPE).
Day 2 - Views on MDR, Brexit update and nanomaterials under REACH
The second day of the conference was held in the Clariant Innovation Center (CIC). Steve Duckworth introduced Clariant to the audience.
The next two presentations were focusing on the Medical Device Regulation. Lars Petersson, Clariant gave the view of a raw material supplier on the MDR. Afterwards Bassil Akra (TÜV) gave insights from the other end of the value chain with a great presentation about the view of notified bodies on the MDR implementation.
Brexit is a hot topic, also in the medical device and pharmaceutical packaging world. Nigel Talboys from Terumo explained the biggest challenges and possible outcomes of Brexit.
Last but not least, Heike Liewald shared Eurocolours' view on the nanomaterial definition, nano under REACH Regulation & EU nano-observatory. She stressed that there are many challenges regarding the regulatory requirements for the pigment & fillers industry.
Steve Duckworth closed the event by thanking all speakers and participants for making this year's summer conference a big success.
The conference showed there are many regulatory challenges like the MDR & the REACH restriction proposal on microplastics. MedPharmPlast Europe will closely monitor the developments and support the policy makers with its expertise.
We at MedPharmPlast Europe are already looking forward to our next event on 17 December 2019. Details will follow shortly.