Tag: Project Management

Pharmaceutical Project Management

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Per definition of PMI (Project Management Institute), project managers across different industries are assigned by the performing organization to achieve the project objectives. This is a challenging, high-profile role with significant responsibility and shifting priorities. It requires flexibility, good judgment, strong leadership and negotiating skills, and a solid knowledge of project management practices. A project manager must be able to understand project detail but manage from the overall project perspective. As the person responsible for the success of the project, a project manager is in charge of all aspects of the project including, but not limited to:

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Pharmaceutical Portfolio Management

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The pharmaceutical R&D portfolio is usually formed by combining several assets. It can include discovery, pre-clinical and development stage small molecules and biologics (Phase I-IV) or medical devices. Continue reading →

Store, Discard or Recycle? – How to Own Your Schedule

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Efficient prioritization and planning should be the two critical skills of every business professional. Planning is a process of thinking about the tasks and goals one wishes to achieve in a given time. Prioritization is a process of ranking the tasks according to their importance and focusing on those which are the most critical or have the biggest potential impact on your goals. Proper planning and prioritization facilitate your and your team success. Continue reading →

Do Not Panic: How to Achieve Inspection Readiness

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pills-1569173_1920-copyInspection Readiness (IR) is a proactive process. It is a process of ‘getting ready’ for an inspection by a regulatory authority (such as FDA), which is conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial.  Continue reading →

Risk Management in Drug Development

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Risk Management is the continuous process of identifying, analyzing and responding to risk factors throughout the life of a project. The risk management starts at the beginning of the project and continues throughout the life of the project. At each stage of the project’s life, new risks will be identified, quantified and managed. Proper risk management is proactive rather than reactive and reduces the likelihood of an event occurring and the magnitude of its impact. Reactive risk management is often called as crisis management. The right balance in risk contingency is necessary; too much may make the project uncompetitive; too little contingency increases the chance of failure. Risk management is a responsibility of the project team and is driven by the project manager. In short, risk management is about anticipating uncertain events that are inherent to a project to optimize them for project success. Continue reading →

Know the Pharma Basics: Drug Development Plan

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Drug development can be described as the process of obtaining the relevant information necessary to be included on your drug prescribing information. Development Plan (DP) is the strategic document that guides the lifecycle of a new product from the pre-clinical lead compound stage through Lifecycle Management (LCM). LCM starts with the first approval of BLA/NDA (first Marketing Authorization) and encompasses development of new indications. In mature pharma organization, DP is approved by the governance bodies. Once approved, it can be regarded as the agreement between executive leadership/board of directors and the program team involved in the discovery, development & commercialization of the product. The DP is a living document and should be amended when the development strategy changes. Continue reading →

The Silent Silo – How to Improve Team’s Communication?

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silo-406957_1920-copyEffective communication builds trust, is critical to the success of any project and represents one of project management’s most important responsibilities. Excellent communication within the project team and between the project manager, team members, and all external stakeholders is essential and is correlated with a high team performance.  Continue reading →

Diversity of Roles in Pharmaceutical Project Management

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banner-1571998_1920_blog-pmPer definition of PMI (Project Management Institute), project managers across different industries are assigned by the performing organization to achieve the project objectives. This is a challenging, high-profile role with significant responsibility and shifting priorities. It requires flexibility, good judgment, strong leadership and negotiating skills, and a solid knowledge of project management practices. A project manager must be able to understand project detail, but manage from the overall project perspective. As the person responsible for the success of the project, a project manager is in charge of all aspects of the project including, but not limited to: Continue reading →