Pharma, Pharmaceutics and Biotechnology Conference

Pharmaceutical product development is the series of complicated operations taken in order to transform the new candidate of a drug into a commercial product available to the patients. This session discusses, in extensive detail, all those stages involved in the process of pharmaceutical product development, namely formulation, manufacturing, and regulatory approval and market launch. Then, the development process begins with drug formulation, which scientists realize the most effective and stable combination of active ingredients, excipients, and delivery systems.

This is the advanced stage to ensure that, though they act effectively, the drugs are safe and acceptable for use among patients. During this stage, solubility, stability, and bioavailability become relevant factors in taking care to maximize drug performance. Once a formulation is developed, it means there is a need to manufacture a product. Any manufacturing executed in this regard must adhere to strict regulatory standards to ensure quality and uniformity. GMP guides the manufacturing process, which requires full documentation, quality control, and validation procedures.

This ensures that every batch manufactured meets the necessary specifications. Quality assurance is another very important component in pharmaceutical product development. Testing is performed at all stages from preclinical and clinical studies, with the objective of answering questions regarding safety, efficacy, and stability.

Stability studies check how the drug behaves through time under different environmental conditions with the objective of proving that the product remains stable and follows its intended effects throughout the shelf life. In addition, regulatory affairs plays a crucial role in the development process. Pharmaceutical companies have to pass through a maze of regulation established by the FDA or EMA to seek approval for the product.

That involves the inclusion of large amounts of data gathered from preclinical and clinical studies with associated IND status applications and NDA.After receiving the requisite regulatory approval, the last step entails launching the product into the market.

Strategic planning for marketing and distribution of the product post-launch will ensure that the drug reaches the right healthcare provider or patient. Real-world surveillance, therefore, monitoring ongoing issues regarding the safety and efficacy of the drug in real life, is in order for instance if new concerns arise.

This session will be aimed at giving participants a good understanding of the pharmaceutical product development process, pointing out some challenges and achievements in that field.

Participants shall be given great insight into what collaborative efforts are required to take a new drug from the lab to market, ensuring that innovative therapies are delivered to patients in safe and effective ways.