Enrolment options

There is currently a strong momentum for the strengthening of the local pharmaceutical sector in developing and emerging markets. Regional and national strategies to promote local pharmaceutical production in line with international standards are being developed.

While the rationale for local production is simple - including factors such as independence from donor programmes which may not run forever, more steady supply chains, and greater control to local regulators - there is still a long way to go and markets are tough. Local companies, especially in low and middle income countries, often face substantial hurdles.

One of the big challenges is the lack of a qualified human resources base in the manufacturing sector of medicines and other healthcare products. In particular, there is need for skilled personnel for quality units (quality assurance, quality control) and other GMP relevant areas. Costs for bringing in experts from abroad are high. Combined with other challenges, local manufacturers often struggle to compete and even survive. Not being in line with international quality standards, they are prevented from passing WHO prequalification, participating in international tenders, and entering international markets.

Moreover, the national medicines regulatory agencies (NMRAs) of these countries experience a shortage too of qualified staff in GMP, GMP inspection and dossier evaluation. This creates difficulties for the NMRAs to enforce internationally acceptable regulatory requirements (including GMP standards) thereby preventing the availability of affordable quality generics for the majority of their low income population groups.

This e-learning course introduces Good Manufacturing Practices for medicines. The course focuses on WHO GMP standards and requirements as one of the major GMPs. Course participants will learn about GMP requirements, including procedural, organizational and infrastructural aspects, as well as about the GMP inspection process. They will be able to critically analyse and implement basic GMP requirements in their daily working routine in the manufacturing and regulatory environment. The participants will practice course contents in quizzes, assignments, and discussion forums.

In the end, these capacity building measures in the area of GMP and GMP inspection will make participants from local manufacturers and national regulatory authorities better equipped for production and regulation of quality assured essential medicines in line with national and international standards.

Course programme

Practical information

Dates: Monday, 23 September 2019, 1:00 PM (Europe/Amsterdam) - Monday, 4 November 2019, 1:00 PM (Europe/Amsterdam) (7 weeks)
Cost: EUR 450.00
Level of effort: 4 hours per week
Certificate: on successful completion
Badge: on successful completion
email info@iplusacademy.org
You can enrol until Monday, 23 September 2019, 12:59 PM (Europe/Amsterdam)


Terms and conditions
  • Since January 2016, i+solutions has established a tiered pricing system for the online courses on i+academy. Following the World Bank classification, applicants from low and middle income countries (LMIC) can enrol at a reduced price. The correct price is given on the enrolment options page and on the pro-forma invoice.
  • Cancellation is only possible before course starting date: the total amount received (excluding bank charges) will be refunded or kept for a future session by written request. Cancellation after the enrolment deadline of the course is not possible. However, if due to unforeseen circumstances a participant drops out of the course during its implementation, s/he can send a written request for re-enrolment. When approved, the candidate will be allowed to re-enrol in a future session within the year after receiving this permission, at an additional cost of 50 euros.
  • i+solutions reserves the right to cancel or reschedule courses in case of unforeseen circumstances. Candidates and sponsors will be notified no later than one week before the start date of the course. The cost of training can be refunded in full, or by written request, be used for a later course session.

There are 2 options for payment. Please choose below.