About this course
The Qualified Person and other Technical Personnel need to be informed and aware of pharmaceutical legislation. Changes in legislation and guidelines, and the interpretation of them, can have significant implications for the individual and their company.
This is the continuation of a very successful series of one day seminars that are designed to form part of your Continuing Professional Development.
What You Will Learn
- The reality and interpretation of recent and new EU legislation
- Changes to EU GMPs
- UK updates
- An update on ICH/International initiatives
- USA changes to legislation and FDA guidance
Who Should Attend
Although designed primarily for Qualified Persons, these seminars provide rapid, efficient updates on issues of direct relevance to Technical Personnel in a broad variety of roles, including:
- Quality Management
- Production
- Engineering
- Regulatory Affairs
- Research & Development
Course outline
- Recent EU Directives and Regulations
- The reality and interpretation
- QP responsibilities
- EU GMP Changes: Updates and Discussions
- UK Developments
- International Developments
- Update on progress with ICH Q4 & Q11 and the IWG for Q8, 9 & 10
- US FDA Changes
Why not bring your problems for discussion?
The seminar offers an ideal opportunity to speak to experienced tutors and to delegates who are in similar roles.
Our seminars are planned to inform you and also to enable you to gain answers to your specific queries via debate, group work sessions and a panel discussion.
Venue
Rome, Italy
This course will take place in Rome, Italy
Venue to be confirmed on a later date.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
Feedback from our previous Italy based course
“Very interesting course: I appreciated the opinions exchanged and different items involved. Thank you!”
Marta Passetti, ACRAF SpA, Italy
“I’ve appreciated the tutors availability for comments and/or suggestions even later on.”
Cecilia Alderigi, Laboratori Baldacci, Italy
“The most important and possitive fact is that the autoclaves from both the EU and US have been presented even in draft or as ‘rumors – very proactive approach.”
Cinzia Mantovani, Actavis, Italy
Feedback from our previous European based courses
“As always a ‘one stop shop’ for ensuring QPs keep abreast of new and upcoming legislation”
Angela White, Ipsen Biopharm Ltd, UK
“Very professional and easy style from the tutors makes the delivery of the detail and complex information easy to assimilate and understand”
Steve Whyard, Genzyme Ltd, UK
“Excellent course to get the flavour of new challenges”
Leonor Arrebola, Centocor BV, The Netherlands
“As good as ever, a great snapshot of recent developments”
Mark Sephton, Napp Pharmaceuticals Ltd, UK
“An excellent walk through of current and prospective pharmaceutical legislation, essential for CPD”
Neil Wayman, AstraZeneca Pharmaceuticals, UK
“Clear and concise presentations giving a good overview of current topics”
Daniel Bell, Napp Pharmaceuticals Ltd, UK
An NSF International Company
