Address: Al Hawiy St., Hitteen Dist., Riyadh , Saudi Arabia
P.O.Box: 13516
Phone: +966920019011
Mobile: +966532375500
Consultation Email: info@mesned.com
Training Email: training@mesned.com
CRO Email: cro@mesned.com
Pharmacovigilance Email: bd@mesned.com
Course Outline
Day One
Introduction
Module 3 ICH,SFDA & EMA guidelines
Module 3.2.S
Module 3.2.S:
Module 3.2.R
QIS/QOS (3.2.R.8)
Day Two
Module 3.2.P
Module 3.2.P
Module 2 link to Module 3
Specific types of products
If relevant and time permitting
TRAINER: SALMA ISMAIL
B.Pharm. MSc (Med); MAP
Salma Ismail. With over 30 years experience & expertise in the Pharmaceutical Industry and in Regulatory Affairs and includes
Legislation, Technical issues, CMC Quality part, Marketing Regulations, Training within the Pharmaceutical industry and covers New
Chemical Entity, Generic and Biological submissions to regulatory authorities within the specific country.
Expertise in academia by lecturing on relevant Pharmaceutical Regulatory matters in Universities in South Africa.
In 2004, her entrepreneurial spirit motivated her to start up her own company - Twinz Regulatory Affairs Pharmacist Consultants. This
company has aided the social standing of the community at large with job creation with the current BBBEE level 1 status.
Twinz Regulatory Affairs Pharmacist Consultants have been instrumental in servicing pharmaceutical companies with new regulatory
submissions and amendments across the African continent with positive outcomes and assisted some of the world leading companies
by providing Regulatory based training to their staff enabling South African Regulatory Affairs on a whole to reach international standard.
MPCC (a member of
Bana Group) was established in 2005 and is now the healthcare industry’s FIRST
choice for sustainable outsourcing of Regulatory affairs, Clinical Research and
Technical consulting services in the Middle East.