Written by Ezra de Leon
Orphan drugs are drugs that treat rare diseases that are life-threatening, seriously debilitating, or cause serious and chronic conditions that affects only a relatively small number of patients.
Rare or ‘orphan’ diseases in Canada are those which affect less than 5 in 10, 000 people. About 6,000 to 8,000 rare diseases have […]
FDA 438 warnings are dreaded by many companies as they affect reputation of those who are concerned. It begins with the issue of FDA 483 form . This may be issued to inform the Principal Investigator or the institution of important unpleasant conditions observed during an FDA inspection. This letter can be issued for many […]
Natural Health Products are a collection of different types of products which are chemically unrelated and are used” in diagnosing, treating, mitigating, or preventing a disease, disorder, or abnormal physical state or its symptoms in humans; restoring or correcting organic functions in humans; or modifying organic functions in humans, such as modifying those functions in […]
Pharmaceutical training is required by the Pharma Industry which in Canada employs more than 60,000 people. Most of them are employed in Montreal and Ontario.
These people are involved in carrying out different pharmaceutical functions such as Research and Development, Quality control and Regulatory Affairs among others. They all need specialized training.
Many pharmaceutical activities are regulated
The […]
The electronic Common Technical Document usually abbreviated (eCTD) was intended to simplify regulatory submissions to regulators of drug approval. It provides a universal standard for pharmaceutical businesses to submit the required information required for approval of a new drug. The eCTD format is now being used in USA, Canada, Europe, and Japan.
It initially started as […]
Clinical Research is an important professional discipline just as Regulatory Affairs. It deals with the art of designing experiments and carrying them out to determine if health products such as new drugs or medical devices are safe and effective for use in health care.
Regulatory professionals require a certain amount of knowledge in Clinical Research as […]
