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Maintaining Compliance

Maintaining compliance with Identification of Medicinal Products (IDMP) standards

Blogs, Regulatory /

The pharmaceutical industry including its operations and associated functions run on data and content. Whether it is safety, regulatory, or clinical data, the pharmaceutical industry and all its stakeholders are actively involved in collecting, monitoring, evaluating, and exchanging crucial information. Indeed, the need for standardization of medicinal product information was highlighted in order to facilitate […]

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Combination Products

Pre-market pathways for combination products

Blogs, Medical Device, Regulatory /

The regulatory landscape for combination products has been somewhat of a “question-mark” for manufacturers for various reasons. This is because when drugs, devices, and/or biologics get combined to produce a combination product, there is uncertainty on which regulatory requirements will apply to the components of the product and the product as a whole. Furthermore, the

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Public Health Emergencies

Mitigating medical device shortages in public health emergencies

Blogs, Medical Device, Regulatory /

The onset of the pandemic amplified an already growing concern in the European Union (EU)- the shortage of medicines, equipment, and devices that subsequently burdens the health system and puts patients at risk. Some of the reasons for these kinds of shortages are related to problems in manufacturing that can delay production, shortages of raw

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Orphan Drugs in Hereditary Angioedema

Access to Orphan Drugs in Hereditary Angioedema

Blogs, Regulatory /

IntroductionHereditary angioedema (HAE) is considered a rare, autosomal dominant disease that is characterized by repeated episodes of swelling which can occur on the face, limbs and even the gastrointestinal and respiratory tracts leading to severe pain, vomiting, and asphyxiation. These swelling attacks may occur unexpectedly and can significantly affect a patient’s quality of life (QoL).

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Digitalization in Regulatory Affairs

Digitalization in Regulatory Affairs

Blogs, Regulatory /

Technology is rapidly driving the growth of the Pharmaceutical and Life Sciences industries. With digital solutions being made more easily available, drug development & pharmacovigilance are transforming to become more efficient, compliant, and patient safety focused. However, regulatory affairs is still somewhat manual where processes and tasks are repetitive, siloed, and resource-heavy. Though Life Sciences

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Clinical Evaluation Report

Medical Devices – Considerations for preparing a Clinical Evaluation Report (CER)

Blogs, Medical Device, Regulatory /

Overview Medical Device manufacturers must demonstrate the safety, efficacy, and quality, of the product and that it functions as intended without endangering the user or patient. The European Medicines Agency (EMA) mandated a clinical evaluation report (CER) that is required to obtain a CE marking for devices that are to be marketed within the European

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Human Medicines

EU regulatory strategic goals for human medicines

Blogs, Regulatory /

The European regulatory system constitutes a network of pharmaceutical regulators from the European Economic Area (EEA), the European Medicines Agency (EMA), and the European Commission (EC). In addition to ensure that patients have timely access to safe, efficacious and high quality medicines, it is responsible for establishing a regulatory environment that keeps up with innovation.

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Pregnancy Prevention Programme

Additional Risk Minimization Measures: Pregnancy Prevention Programme

Blogs, Pharmacovigilance /

IntroductionThe practice of pharmacovigilance revolves around patient safety by improving the benefit-risk balance of a pharmaceutical product. This is done by alleviating the extent of the adverse reaction associated with it or by enhancing its benefit. Routine minimization measures such as specific dosing regimens, warnings & precautions communication through labeling , patient follow-ups, relevant testing

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