6. Recommendations and Results of Activities for the RMP from the Japan Pharmaceutical Manufacturers Association Data Science Expert Committee
10.3820/jjpe.19.143
- VernacularTitle:6. 日本製薬工業協会データサイエンス部会からの RMP に対する活動成果と提言について
- Author:
Genta KAWAGUCHI
;
Keiji IMAI
;
Tatsuya KANEYAMA
;
Toshifumi KAMIURA
;
Masaki KAWANO
;
Tetsushi KOMORI
;
Motonobu SAKAGUCHI
;
Hironori TAKEI
;
Yuki TAJIMA
;
Tomomi KIMURA
;
Yasuyuki MATSUSHITA
;
Hironori SAKAI
;
Osamu KOMIYAMA
- Publication Type:Journal Article
- Keywords:
risk management plan;
safety specification;
pharmacovigilance plan;
PECO (PICO)
- From:Japanese Journal of Pharmacoepidemiology
2015;19(2):143-151
- CountryJapan
- Language:Japanese
-
Abstract:
MHLW released a guideline for Risk Management Plan (RMP) in April 2012, in order to manage the risk of pharmaceutical products from the development stage towards post marketing period. The guideline suggests to determine Safety Specification and to develop Pharmacovigilance Plan (PVP) and Risk Minimization Plan aligned to the ICH E2E guideline. However, in some of the RMPs, which had been published online (as of August 2014), conventional (Special) Drug Use Results Surveys are planned as a “universal” PVP regardless of the impact, severity and characteristics of the risks. Our JPMA taskforce (Data Science Expert Committee) summarized report and published in August 2014. In this report, we explained how to evaluate safety events based on evidence level for safety specification and how to develop PVP. Also, we would like to propose KAIZEN activities for RMP improvement as follows:
1. In order to clarify the research question, rationale and evidence for safety specification should be evaluated carefully.
2. It is essential to be considered in advance how to collect and analyze the safety data for detecting safety specification during clinical development.
3. Safety profiles should be discussed thoroughly on DSUR development among stakeholders in order to clarify safety specification at NDA. Research questions for each different risk and missing information should be established according to PECO, which will flow into appropriate PVP planning.
4. Continuous PDCA cycling is critical for RMP. The first survey or research will bring you next research question (s).
We expect all stakeholders, including clinical development specialists in industry, regulatory authorities, and academia, to have better understating of RMP principle and to manage and implement it more appropriately in a scientific manner.
