Tuesday, 24 May 2011

Pharmaceutical Regulatory Affairs in the EU and US

With so many things I have had to do lately it has been very difficult for me to update the blog as often as I initially planned.  However, I will spare sometime this afternoon going through three posts I have been planning to write and share with all of you for quite some time now. The first one has to do with a strategy (if I might label it that way) I have decided for, in order to enhance my employability. The reality is that nowadays nailing that dream science job is ever more difficult. I am not going to discuss the reasons why, they are known to every single one of you and the "blunt" rules of diplomacy tell me to just leave it for some other time. Nevertheless, that is the reality in Europe where the higher rule states that if you are not willing to travel abroad ONCE AGAIN, for like the FOURTH time in your life, then you should not wait for more opportunities but the ones to which you're restricted due to your "poor" choice of Time Zone!

Along with other decisions I put in practice, like volunteering in the Frozen Ark Project - School of Biology (University of Nottingham) and the science writing that has been helping me loads these days, I searched the market for an interesting, promising and professional course that would guarantee me three key things: 1) Something I am passionate about, 2) Something that offers future perspectives, and 3) Something that can enhance my employability in the near future.

Well, after browsing and browsing I found just that. A course on "Pharmaceutical Regulatory Affairs in the EU and US" "offered" by PTI - Pharmaceutical Training International. For those who might not be entirely familiar with this entity, as stated in their website "PTI is an internationally renowned training company specialising in public, on-site and distance learning training initiatives. Our highly experienced faculty of trainers provide the very latest information on pharmaceutical compliance, operational and strategic issues". I am now enrolled for this course and I will start it asap. If you are interested in something of these sort, ask for Gerald Okullo, he basically helped me through the process and he was a very kind, patient, understanding and customer-friendly, customer-oriented individual. PTI should thank him for the money I am putting into this course as I was properly served by his initiative and guidance. 

So, if you want to know what I am to learn and how convincing the modules and different chapters of this course were to me, just take a look down here as I am listing you the summarised info. As I progress through the course it is obvious I won't provide you with any of the content because I do respect copyrights, but I will definitely tell you my opinion, in a scale from 0 to 10 of how interesting and useful I find each module of this new project of mine. So, go on and take a look at what the modules include:

  • Module 1 – Introduction and EU Overview
    - Origins and purposes of regulation
    - Basic elements and approaches in regulation
    - EU institutions and legislation
    - Approaches to EU registration
    - Centralised
    - Mutual Recognition
    - Decentralised
    - National
    - Role of the regulatory affairs professional
  • Module 2 – US and International Regulatory Overview
    - US FDA overview
    - US Administrative procedure
    - FDA Good Guidance Practices (GGP)
    - Appeals procedure
    - Regulatory bodies in other countries
  • Module 3 –Product Development
    - Introduction to ICH
    - Preclinical studies
    - Good Laboratory Practices (GLPs)
    - Clinical Trials/Good Clinical Practice
    - EU Clinical Trials Directive
    - EU privacy legislation
    - FDA clinical trials regulation
  • Module 4 – Applications for Market Authorisation: General Approach
    - ICH Common Technical Document
    - EU and FDA similarities and differences
    - Quality (Chemistry/Manufacturing Controls)
    - Safety
    - Efficacy
  • Module 5 – Regulation of generics and innovator rights
    - Abridged applications for generics
    - Introduction to Intellectual Property Law
    - Bolar issue
    - Supplementary Protection Certificates
    - US patent term restoration - EU/US regulatory exclusivity periods
    - Orphan drugs regulation
    - EU/US parallel trade issues - Programmes for developing countries
  • Module 6 – OTCs, Herbal Medicines and Homeopathics
    - Homeopathics
    - Herbals
    - Radiopharmaceuticals
    - Influenza
    - Vaccines
    - Narcotics/controlled drugs
  • Module 7 – Biologics, Novel Therapies and other Special Categories
    - Biologicals and Biosimilars
    - Blood and blood products
    - Cells, tissues, organs, gene therapy, cloning
    - Renewals
    - Variations
    - Product Master Files
  • Module 8 – Safety and Quality Regulation
    - Labelling overview, EU/US
    - Pharmacovigilance in the EU
    - Pharmacovigilance in the US
    - GMPs
    - Inspections
    - Enforcement in the US
    - Enforcement in the EU
  • Module 9 – Advertising and marketing practices
    - Role of pharmaceutical industry in both promotion and medical education
    - EU Community Code on Medicinal Products
    - EFPIA and ABPI Codes and national codes
    - FDA regulation
    - Leading US and EU cases
    - Compliance strategies
  • Module 10 – Other EU and US regulation
    - EU price, reimbursement, cost-benefit review
    - US Medicare/Medicaid
    - UD Drug Enforcement Administration
    - US Federal Trade Commission
OK, my next post will come very soon  to The Toxicologist Today, and will tell you about my  first publication (as a third author but I am very proud of it) and my upcoming projects in Science where you can even, as usual, offer me your wise and experienced comments.

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