Yearly Archives: 2016
TGA Inspections are Coming – Is your Company Ready?
The TGA has recently concluded its pilot program in Pharmacovigilance inspections in Australia. Numerous companies volunteered to take part in this inspection program, and from those volunteers the TGA selected ten companies. The selection process by the TGA considered a) … Continue reading
What is food for special medical purposes (FSMP)?
With a greater recognition of the importance of nutritional support in medical therapy and improved technology, the “food for special medical purposes” (FSMP) market is currently surging. However, many questions arise, what is food for special medical purposes? Where can … Continue reading
Stressed? Well your products should be!
Treating your drug substance or drug product with an acid, a base, an oxidising substance, heat or exposing it to direct light might sound extreme, but that is exactly what the TGA want to see in your registration dossier. Assay … Continue reading
Proposed updates to GVP Module VI and what this might mean for our clients
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. The … Continue reading
Medicine labels: TGO 91 and TGO 92. What’s the impact?
Following years of consultation and review the TGA has issued two new labelling orders to replace the current Therapeutic Good Order No. 69 for specific medicine labelling requirements: Therapeutic Goods Order No. 91 – Standard for labels of prescription and … Continue reading
Patient support program – the key driver of better health outcomes
Pharmaceutical companies play a key role in supporting the quality use of medicines through patient focused programs. These programs are designed to aid compliance and lifestyle choices. They provide significant value to patients through the accessibility of information and support. … Continue reading
Commercial Eyes Recruiting: Regulatory Services Manager
Commercial Eyes has a great opportunity for a Regulatory Services ManagerReporting to the Director, Regulatory Services, the Manager is responsible for the day to day operational management of the regulatory team and the assigned project portfolio within the Regulatory Services … Continue reading
Commercial Eyes Recruiting: Senior Market Access Consultant
Commercial Eyes has a great opportunity for a Senior Market Access consultant to join our dynamic Market Access team. Reporting to the Health Economics and Market Access Manager, this senior consulting role offers the successful candidate the opportunity to gain … Continue reading
Warning: This medical device literature review may contain traces of LBS
With the release of new clinical evidence guidelines for medical devices, sponsors and manufacturers will be expecting some further guidance on the structure, content and quality of their clinical evaluation reports (CERs). Once final, this guidance will be used in … Continue reading
Ready? Get Set…Go! Planning the most appropriate strategy for your product to enter the Australian market
As we weave our way through life, we plan…plan our career, plan our finances, plan a holiday and most of us would have at least once in our lifetime planned a party. The key to a successful plan is finding … Continue reading
