News & Events
'UK Regulatory Landscape Post-Brexit' with Malgorzata Sypniewska
Topics:
- Brexit and Northern Ireland Protocol
- PV requirements including PSUR
- Establishment of MAH and Marketing Authorisation types
- MHRA’s adjustment of regulatory pathways following Brexit
- UK requirements vs EU- similarities and exceptions
- Windsor Framework
- New IRAS (Integrated Research Application System) for clinical trials
- Regulatory Connect
- Q&A
Biography:
Malgorzata is a qualified pharmacist with 10+ years of experience. She worked in Polish and Irish community pharmacies prior to stepping into a pharmaceutical industry. In 2015 she joined a Clinical Research Organization (CRO) as a Medical Information and Pharmacovigilance Specialist, and throughout the years of working on diverse range of projects she has gained skills and expertise which led her to become a Global Senior Regulatory Affairs Manager.
https://us06web.zoom.us/j/87658252301?pwd=vE5RVwVdFMPLH7vBvJuDmUAu0DV5TF.1
PIER Mentorship Programme Background
In 2017, PIER ran a six-month pilot mentorship programme to support experienced pharmacists working in patient-facing roles and early industry career pharmacists develop their careers. Twelve pharmacists participated (8 patient-facing and 4 industry based). The pilot was supported by an external career consultant who assisted with the development of a framework for the initiative.
Following the successful pilot in 2017, PIER ran mentorship programmes in 2018 and 2021. Mentees were matched with experienced industry-based pharmacists (mentors) working in the area of expressed interest of the mentee e.g. Market Access, Medical Affairs, Quality, Regulatory Affairs. Participants also attended a one-day workshop facilitated by the external career coach.
2024 Mentorship Programme
The PIER Committee is organising another mentorship programme for pharmacists (> 3 years qualified in Ireland or abroad) interested in exploring other career options.
Call for Mentees
Call for Mentor Volunteers
The PIER Committee are looking to establish a panel of experienced industry-based pharmacist mentors who fulfil the following criteria:
- Have at least 5 years post-qualification experience, currently working in an industry or regulatory agency role.
- Can commit to supporting a fellow pharmacist looking to make a career change.
- The time commitment is envisaged as at least once a month meeting (online or f2f) for a period of 6 months and attendance at an evening briefing webinar in June 2024.
If interested in participating as a mentor, please email education@pier.ie before Friday 24 May 2024.
Please register your interest in attending at the link here: https://forms.gle/ZxDXCP4vL7ASQ6MC8. Registered attendees will be provided with a Zoom link ahead of the webinar.
Useful Links
- Academy of Pharmaceutical Sciences (APS)
- European Industrial Pharmacist Group (EIPG)
- European Industrial Pharmacists Group Newsletter
- European Medicines Agency (EMA)
- Health Products Regulatory Authority (HPRA)
- Irish Institute of Pharmacy (IIOP)
- Irish Medical Device Association (IMDA)
- Irish Pharmaceutical Healthcare Assocation (IPHA)
- Pharmaceutical Managers Institute (PMI)
- BioPharmaChem Ireland
- The Pharmaceutical Society of Ireland (PSI)
- UK & Ireland Controlled Release Society (UKICRS)
- The Organisation for Professionals in Regulatory Affairs (TOPRA)
Find out more about the PBF and the work they do 