Overview: Risk Management Plans (RMPs) have become a key topic in Pharmacovigilance (PV) since the 2012 European PV legislation has come into effect. Following the example of the European Union, many other countries have followed the example of the EMA and started requiring detailed plans on how the important risks of therapeutic drugs are to be minimized and/or further characterized. Such RMPs nowadays constitute an important part of the registration package of a new drug and are frequently also required for established drugs, in particular when these are submitted for new indications.

Date : 11th February 2015 to 11th February 2015

Place : United States, Fremont

Website :http://www.compliance4all.com/control/w_product/~product_id=500165LIVE/

Contact Person:Adam Fleaming

Description:

Overview: Risk Management Plans (RMPs) have become a key topic in Pharmacovigilance (PV) since the 2012 European PV legislation has come into effect. Following the example of the European Union, many other countries have followed the example of the EMA and started requiring detailed plans on how the important risks of therapeutic drugs are to be minimized and/or further characterized. Such RMPs nowadays constitute an important part of the registration package of a new drug and are frequently also required for established drugs, in particular when these are submitted for new indications.

Overview: Risk Management Plans (RMPs) have become a key topic in Pharmacovigilance (PV) since the 2012 European PV legislation has come into effect. Following the example of the European Union, many other countries have followed the example of the EMA and started requiring detailed plans on how the important risks of therapeutic drugs are to be minimized and/or further characterized. Such RMPs nowadays constitute an important part of the registration package of a new drug and are frequently also required for established drugs, in particular when these are submitted for new indications. will be held in Fremont,United States on date 2015-02-11

---

Deadline for abstracts/proposals : 10th February 2015

Keynote Speakers :

Check the event website for more details.