Pharmaceutical Legislation Update

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
• An update on ICH and other international initiatives
• USA changes to legislation and FDA guidance
• UK updates

Course outline

Recent EU directives and regulations

• The reality and interpretation
• QP responsibilities

EU GMP changes: updates and discussions

UK developments

• MHRA news/inspections

International developments

• Update on progress with guidance from ICH, PIC/S, etc

USA 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

Manchester Airport Marriott Hotel, Manchester, UK

The Manchester Airport Marriott Hotel is just five minutes by courtesy bus from the airport and railway station. Transport will also be available, free of charge, at the close of the course to take you from the hotel to the airport. Situated adjacent to the M56 motorway, it is also easily accessible by road.

With its comfortable bedrooms, swimming pool and fitness room, the hotel is an excellent place to relax as well as learn.

Hotel Accommodation

• Online early booking offer – we have negotiated a discounted bed and breakfast rate including free wi-fi.
• To take advantage of this offer, you must book via a special weblink, details of which will be provided to you on receipt of a completed booking form.
• This offer is only available until four weeks before the course start date, after which point the hotel cannot guarantee room or rate availability.
• If you need any help or guidance with the accommodation booking process, please contact our course administration team.
• Your account with the hotel should be settled at check-out.
• Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.

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:

• 

  Mr Peter Gough
  Partner
  MSc, CSci, CChem, FRSC, FCQI, CQP

  • [email protected]
  • +44(0)1751 432999

What you've said

“It was good to get an independent view from experts and this allowed me to clarify my interpretation of the changes into something realistic at work.”

Adam Haigh, Perrigo UK Ltd, UK

“An excellent summary of the current and future state of play in the regulatory arena globally. An essential course for myself as a QP.”

David Preston, Colgate Palmolive (UK) Ltd, UK

“Excellent value for money. Content and delivery very high standard.”

Mark Dignum, Contract QP Ltd, UK

“A great way to get a good bite sized appreciation of current and planned legislation changes accompanied by a high level of enthusiasm from the presenters!”

Robert Hughes, AstraZeneca Pharmaceuticals, UK

“Certainly important to keep up to date with legislation – will definitely bring this back to site/group as an ongoing requirement in future.”

Michael Kirk, Cara Partners Ltd, Republic of Ireland