6 Ways to Adapt to the Changes in Regulatory Affairs

Hi! I hope that you are having a wonderful spring day with beautiful weather at the beginning of May. At this time of the year I feel more energetic and want to do many things: Write my blog, prepare my training videos, have progress in my business and so many other things. Do you feel it too?

Well, just like you and me, many people are trying to do so many things at a time these days. I had a small survey on which topics my colleagues were struggling with, in Regulatory Affairs (RA) these days. Most of the responses were about the fact that they had hardships with adapting to the continuous changes in Regulations. Inevitably, we all need to go through changes. If you are having a similar problem, here are 6 ways to solve this issue:

1-Be Curious about the Change!

I believe that adding the following links in the websites below, to your favorites and checking them on weekly basis (at least) would really help:

  • On the EMA website (ema.europa.eu) go to “What’s New?” under “News & Events” Section. The link is below:

www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/landing/whats_new.jsp&mid=WC0b01ac058004d5c4

  • On the FDA website (fda.gov) go to “Newly Added Guidance Documents” under “Guidance Compliance & Regulatory Information” section. The link is below:

www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm121568.htm

You can also sign up in order to get the updates in Recalls, Market Withdrawals, & Safety Alerts with the link

www.fda.gov/Safety/Recalls/default.htm

  • On the WHO website (who.int) go to “WHO News” under “Mediacenter” Section in order to get the updates in guides and news as well. The link is below:

www.who.int/mediacentre/en/

  • On the website of Health Canada (hc-sc.gc.ca) go to “What’s new” Section Under Regulatory Transparency and Openness. The link is below:

www.hc-sc.gc.ca/home-accueil/rto-tor/index-eng.php

2-Table of Change Really Works!

Make a list of the topics that are important to you in RA and put them in a table. And add small notes in every change referring to it in the table with the dates. So this will keep you alert to track the changes and how you can handle your work in advance. But remember to keep it updated all the time.

3-Use Social Media

You can follow the updates in regulations in social media, like LinkedIn, Twitter as well. Get into groups and join the discussions, forums. There are many topics on news in healthcare and RA issues. People in your network may guide you as well.

4-Follow Some Blogs

There are many blogs in pharmaceutical industry nowadays written by people from all around the world. Just like mineJ. There are also blogs of agencies as well as pharmaceutical companies. You can be aware about the progress and the changes in the market when you follow the ones suitable for you.

5-Participate in Seminars, Meetings as well as Webinars and Webcasts

Seminars and meetings are a great chance to discuss the updates with your colleagues. Moreover, there are many webcasts and webinars on the internet to have this chance more often and get more attendance. There are many webcasts and webinars that provides colleagues to discuss more specific topics. This is a good way of interacting with colleagues and sharing information and find solutions.

6-Ask a Consultant for Guidance

You can always ask for support when you are stuck with something. Do you feel like you are not sure about the update in the regulation and cannot get sufficient information from the web? Are you hesitating whether there is a change and would like to know more about the regulation of the country you are working with? Then it is safe to ask for guidance from a consultant who is more informed about that market.

I will be really glad if you share your comments with me. Have a wonderful week!

www.pelinboran.com

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