Floyd will lead Dohmen's growing regulatory consulting practice as well as a portfolio of pre-commercial and post approval outsourced services in quality, regulatory, pharmacovigilence
, REMS, medical affairs and medical communications.
This concept, which was originally defined for the drug pharmacovigilence
in Western medicine (Alvarez-Requejo et al 1998), also has relevance to the domain of acupuncture.
Orlandi will be responsible for leading Clinical Development, Medical Affairs, Pharmacovigilence
and Regulatory Affairs for the Company, including its Phase 3 clinical trial program for flurpiridaz F 18.
This is expected to include updating dossiers of selected products to help advance the emerging market strategy, investing in pharmacovigilence
activities, and establishing a central database of regulatory information.
From 2008 to 2009, Keller served as vice president of regulatory affairs and pharmacovigilence
for Medicis Pharmaceutical Corp.
Pinnacle provides a full range of services including regulatory, sales, marketing, distribution (including billings and collections), pharmacovigilence
, product safety, market research and administrative services.
Regulators will raise the bar for innovation, drug approvals and pharmacovigilence
More transparency over pharmacovigilence
data and reporting;
The final section contains a chapter on clinical toxicology (acute overdose management), regulatory aspects of safety assessment, and pharmacovigilence
Regulators will take a more proactive stance that will raise the bar for innovation and drug approvals and pharmacovigilence
will be the story.
A potential excess of AEs is often defined as any product-event combination with a score exceeding the specified threshold (FDA Guidance for Industry: Good Pharmacovigilence
Practices and Pharmacoepidemiologic Assessment, 2005).
Kamemoto will have primary responsibility for leading and directing all regulatory affairs and global pharmacovigilence