#PVA #SDEA #agreements #contracts #pharmacovigilance #drugsafety At least, the ADES should allow for a rapid exchange of all serious adverse events (CAS) to determine if expedited notification is required. This applies to both clinical and post-marketing trial situations as well as specific programs such as patient assistance programs. Some companies only want MedWatch or CIOMS I forms for each case; Others also want source documents. The processing of security data varies somewhat between the United States, the EU and other areas, but, in general, the obligation to expedite security reports on suspected serious adverse events to the relevant authorities is similar, at least from areas. The period during which reports are to be received begins when the report is received by the third-party/subcontracting provider, NOT when the report reaches the MAH. It is therefore in the interest of the MAH that the reports be forwarded to them (or to the service provider) in order to obtain them as quickly as possible, so that they can be processed properly and on time. One of the most recent major trends in the pharmaceutical world is the joint development and commercialization of drugs. This includes all possible agreements with other companies, both domestically and abroad. We can now see several companies that market the same drug in the U.S. and other companies that market the drug overseas.
Clinical trials can be conducted jointly or outsourced to CROs or other partner pharmaceutical companies. In many companies, the legal department knows all the partners involved in the marketing of companies` products. In large companies that sell hundreds of drugs in more than a hundred countries, there can be tens of thousands of such contracts! This was certainly the case in one of the large companies where I worked for many years. We have had more than 10,000 contracts in approximately 110 countries around the world. Maybe there`s a database with them. You can live in several places around the world and many are not in English. In my experience, legal services are happy to help with drug safety with ADES, but they often know nothing about all the contracts that exist in the world. Sometimes the financial department is better informed of all agreements around the world, because they have to send and receive money! SDEAs can be requested for inspection in accordance with both fda and EU drug safety rules. Within the EU, the SDEA must contain at least, but not exclusively, the names and contact details of the qualified person competent in pharmacovigilance, any party responsible for monitoring the literature, collecting and filing the ICSR to the relevant authorities, the letter and filing of PSUR, the RMP, the detection and management of signals, the response to requests from the competent authorities who deal with complaints, etc. Depending on the request, the SDEA may include the allocation of responsibilities for the EU QPPV, the PSUR letter, literary research, reporting to regulators, answering regulatory questions, handling product complaints, signal recognition, hosting the safety database and continuous assessment of profit-related risks.
Where some or all of the pharmacovigilance activities are outsourced, including medical information, call centres, treatment of undesirable undesirables, the ADES must be complete and specify which parties are responsible for which activities, although the ultimate responsibility lies with the MAH. The types of data and activities regulated by ADES differ from company to company and from product to product.