Pharmacovigilance- Knowledge Repository

What I like about working in Pharmacovigilance is the opportunity to learn new things everyday!

Keeping yourself updated with industry knowledge and upgrading your skills is important in every fields and also in pharmacovigilance. My opinion is, it is actually more important in pharmacovigilance, as this domain is tightly governed by laws, regulations and guidance’s set by regulatory agencies of country, which get updated or undergo changes frequently. Additionally there is an update in the medicine and scientific area of drugs too.

I thought of enlisting few websites or blogs that I found useful to keep myself updated on industry trends and updates in pharmacovigilance. This blog will not be covering websites or blogs or journals related to medicine as it deserves a separate write up.

https://www.cinglevue.com/growing-learning-mindset-whats/

1) Regulatory Agencies/Health Authority websites:

These websites are great source of information for enhancing knowledge or refreshing one's memory or simply keeping in touch with regulatory updates. If you subscribe to this websites, then any new updates from regulatory agencies will be delivered to you in your mailbox.

FDA for US regulations, EMA for European regulations, MHRA for UK regulations, TGA for Australia, PMDA for Japan,ANSM for France and so on.

1.1 FDA website- It is storage of vast knowledge on varied number of topics, but browsing the website is bit troublesome, but once you get hang of it, lot of required information and in fact free courses and documents become available to you. There is an option to subscribe (link below) to any new articles or changes that you can receive in email box:

https://www.fda.gov/industry/industry-notices-and-guidance-documents 

1.2 EMA website-It is very informative and user friendly website, navigation is quite easy and finding topics of your interest is bit easier. I have enlisted the main page of EMA, from here, navigation is possible to topic of your choice.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000258.jsp

1.3 MHRA-This is a Website of UK’s Medicines and Healthcare products Regulatory Agency and is very informative. Especially availability of SmPC (Summary of Product Characteristics)/ package Insert/CCDS) in alphabetical order. Additionally, they do have lot of other information such as drug safety updates, recalls, rules and regulations updates etc.

 All the updates are easily visible on website.

https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures

1.4) CDSCO-The Central Drugs Standard Control Organization (CDSCO) website of India's regulatory agency is quite informative, but I feel the website needs more information and more updating on frequent basis. Link is https://cdsco.gov.in/opencms/opencms/en/PvPI/  . You can also refer to more PV dedicated link which is PVPI (Pharmacovigilance Programme of India) https://ipc.gov.in//PvPI/pv_home.html 

1.5) UMC-  Uppsala monitoring centre based in Sweden is an independent, not profit foundation and is headquarters for all PV activities. It is the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. UMC operates the technical and scientific aspects of the WHO’s worldwide pharmacovigilance network. They have number of courses available (online,conference,workshop) and huge number of articles from UMC,WHO and Scientific publications.

https://www.who-umc.org/

1. 6) ICH website- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration and has published guidelines that remain to be accepted by almost all regulatory agencies especially the key one’s e.g. US, Japan and EU.  And this are basis to national PV guidelines of many countries.

All required documents and guidelines like ICH E2A, ICH E2B etc are freely available for download.

https://www.ich.org/home.html

2) Miscellaneous

There are number of other sources to read about PV such as  blogs, website,institutes, pharma companies, journals.  They do provide good content, good training and learning course materials. I have mentioned few of them, but does this should  not be taken as my personal endorsement (I have no invested profit interest in them).

2.1) DSRU: This institute provides paid training courses in Europe mostly, check out website the courses appear very well designed and informative. But they appear to be bit costly.The advantage is to go for diploma and masters and with online course availability, they have done a good job.

https://www.dsru.org/

2.2) EU2P: This offers courses mainly on European regulations. The courses are available on variety of topic and the scores can be collected to qualify for diploma, masters or certificate course. They have online learning option.

http://www.eu2p.org/diplomas-offer/certificates

2.3) ISOP : International society of pharmacovigilance also offers courses and training materials. They also arrange events and conferences. It is beneficial to take their membership and they offer reduced membership fee for low income countries and students etc.

http://isoponline.org/

From https://www.urbanpro.com/a/6-tips-efficient-online-learning

2.4) Online portals: Many other company owned websites  host lot of updates on pharma domain news like pharmabiz, pharmatutor, Fierce pharma-http://www.fiercepharma.com/, They are more like online newspaper.

2.5) Blogs : There are not many blogs that I found useful talking only about PV. However many CRO’s post PV topics on their company blog, where they ask their PV experts to write articles on PV topics, this is worth reading and following.

2.6) Social media: I do not know much about Facebook, except few PV dedicated pages but they post only job listings, but Linkedin is very good tool to keep in touch with domain knowledge, there are many PV groups that you can join where articles on PV topics are posted like Pharamcovigilance professionals, Drug Safety, Medical Affairs, Pharmacovigilance experts, PV India, clinical trial group etc.

2.7) Youtube: This is good for people who prefer video content. Few listed below.

https://www.youtube.com/watch?v=Ww75dFrhEYs

https://www.youtube.com/watch?v=z2lU_TGhSDE

Thanks you for going through this exhaustive list, which is just a small effort from my side to share the knowledge.  If you know any other good sources, I will be happy to take a note of same.

Written by

Dr.Shraddha Bhange.

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