Outsourcing is a common practice in the pharma and biological industries. Manufacturers of pharmaceutical and biological products outsource many of their manufacturing processes to contractors/suppliers. This arrangement bestows many benefits for both sides. However, lack of clarity about the terms of the contract can become a cause for contention when there is a disagreement or dispute between the parties. In fact, lack of clarity can be a primary cause for disputes and disagreements.
The root of these problems lies in the inability of the concerned parties to thoroughly and properly delineate roles and responsibilities and set up proper mechanisms for the resolution of these issues when signing agreements. One of the crucial areas of the agreement pertains to the development, support and updating of confidential Technical Files (Drug Master files). Drug Master Files are documents which allow suppliers to protect their confidential product and process information from each and every customer, which they share with only the regulatory agencies.
Full understanding of Quality Agreements and DMFs
So, a clear understanding of what the regulatory agencies around the world look for in the DMFs is imperative for suppliers to ensure that their agreements with contractors/suppliers are drafted and implemented without any misunderstanding. Quality Agreements and Drug Master Files, which are at the core of these arrangements, need to be drafted thoroughly. To do this, a complete understanding of the rationale behind the Quality Agreement and the Drug Master Files is a must. This is exactly what a seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.
This two-day, in person seminar will have Robert J. Russell, President/CEO of RJR Consulting, Inc., as Director. RJR Consulting specializes in helping clients navigate through global regulatory compliance requirements for pharmaceuticals, medical devices, biologics, combination products and dietary supplement/OTC products. Bob has specific expertise helping companies expand into new regions globally and meet establishment and licensing requirements, clinical trial data expectations, marketing authorization/registration preparation, and meet variations/amendment filing responsibilities and license renewal filings.
How DMFs are viewed by the different regulatory agencies
Aimed at professionals involved in the areas relating to pharmaceutical, biologic and medical device products, components, and packaging materials, such as manufacturing, Regulatory Affairs, project management, global supply chain, research and development, Quality Assurance and control, validation, and development, preparation of submission materials and General Management; this course will describe the current review and enforcement environment within FDA, as well as the manner in which Drug Master Files (DMFs) are reviewed by the agency.
Bob will also familiarize participants with the use of DMFs in the EU, Japan, Canada and Australia, during which he will highlight both the similarities and differences these countries’ regulatory requirements have to the U.S. system.
The important learning objective this course will impart is a grasp of how to prepare Quality Agreements and Drug Master Files (DMFs) with the FDA, with an understanding of the rationale behind doing so. Practical knowledge of what reviewers look for in DMFs, the consequences that can be expected as a result of non-compliance, and the strategies for avoiding the most common DMF-related errors are the other important learning outcomes of this course.
Bob will also explain how DMFs are organic by their nature, and will present strategies for establishing and maintaining effective change control programs. He will also show how to facilitate effective communications with regulatory agencies along with customers and vendors.
Of late, the FDA has been transitioning from a paper filing system to electronic submissions for initial DMF submissions, annual updates and DMF amendments. Bob will discuss this development as well.