(MA). Thus, all OTC drug products have the PV requirements for prescription requirements (expedited reporting, PSURs, signaling, etc.) Local requirements should be checked for products, such as neutraceutical and herbal preparations, etc. Agencies collect AEs on OTC products (e.g., the Medicines and Healthcare Products Regulatory Agency, MHRA, collects them under its Yellow Card Scheme). In other words, PV requirements for an OTC drug in the EU are the same as for Rx drugs.
If a product is sold in both the US and the EU, in practice, the product is handled as a drug with expedited reporting, PSURs, and so forth, for global use, although some documents (e.g., aggregate reports) would not be submitted to FDA if not required.
Staying Up to Date
As noted in multiple places throughout this manual, the world of drug safety is changing almost daily. Personnel handling drug safety and PV must stay up to date with changes that occur both in the scientific and medical world (new SAEs, new interactions, etc.) for drugs they handle and in the regulatory–operational world. The best way to do both is through journals, meetings, and conferences and the Internet.
Scientific/Medical Literature
New and important medical information on areas that involve drug safety are found in many medical journals throughout the world, including major pharmacology and medical publications, such as the New England Journal of Medicine, the Lancet, the Annals of Internal Medicine, and specialized drug safety journals, including:
Drug Safety is published by Springer/Adis (https://link.springer.com/journal/40264).
AdisInsight Safety is a worldwide resource for PV literature monitoring. It provides access to published adverse drug reaction case reports, drug safety studies and regulatory news covering all drugs and therapeutic areas, updated daily https://www.springer.com/gp/adis/products-services/adisinsight-databases/pharmacovigilance/pharmacovigilance-insight/32568
Expert Opinion on Drug Safety (http://www.tandfonline.com/loi/ieds20) covers medical issues on particular drugs.
Pharmacoepidemiology and Drug Safety is the official journal of the International Society for Pharmacoepidemiology (http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1099-1557).
Therapeutic Innovation and Regulatory Science, formerly known as the Drug Information Journal, published by the Drug Information Association. This journal carries articles on the whole field of pharmaceuticals, including sections on drug safety (http://journals.sagepub.com/home/dij).
There are online and open access journals published now that cover many medical areas including PV. Some claim to be refereed.
There are also multiple blogs that cover PV news. They vary in reliability in many cases. There are also many PV groups on various websites, such as LinkedIn. They also vary in terms of reliability.
Meetings and Conferences
Many conferences cover drug safety only or have sections dedicated to drug safety.
Drug Information Association (DIA) holds many conferences in the United States, Europe, and Asia, as well as sessions before and during annual meetings. Each January, conferences on drug safety are held in Washington, D.C., and there are annual conferences in the EU (https://www.diaglobal.org/).
Other private (non-profit) organizations offer training, including the Pharmaceutical Education and Research Institute (PERI) (www.peri.org), the Uppsala Monitoring Centre) ((https://www.who-umc.org/) and the Drug Safety Research Unit (http://www.dsru.org/courses/). The EMA and MHRA do occasional PV training sessions.
The International Society for Pharmacovigilance (ISoP) holds meetings and training courses (http://isoponline.org/).
International Society for Pharmacoepidemiology (ISPE) has conferences, meetings, and training courses (https://www.pharmacoepi.org/).
The FDA and certain other agencies hold advisory committee meetings and public hearings that are open to the public. Some are also transmitted online or are available as podcasts or webinars on the respective websites.
The Regulatory Affairs Professionals Society (http://www.raps.org) has training sessions and conferences on the general field of regulatory affairs and sometimes addresses drug safety.
Many private, for-profit organizations train in drug safety on all continents. They are best found by doing a Google search on drug safety conferences. They vary in quality. Caveat emptor.
The Internet
There are many resources on the internet. They are ever-changing, with new ones appearing, old ones disappearing, and current ones changing:
Government e-mail alerts, e-newsletters, Facebook, Twitter and others: The FDA, EMA, MHRA, Health Canada, TGA, and many other governmental agencies issue periodic alerts in various fora.
Fierce Pharma (https://www.fiercepharma.com/): This is a set of daily publications on various areas of the industry.
Blogs: There are many blogs on the pharma industry, some serious, some outrageous, some outraged, all opinionated. They change frequently and their credibility varies. Best found by a periodic Google search. Caveat emptor.
Google Alerts: An excellent Google function is called Google Alerts. This is an automated mechanism that can be set up on Google to deliver, as news becomes available, daily or weekly information found
