Advice for a New Project Manager

 

Project management is as demanding as it is rewarding. Your new role places you at the nexus of strategy, execution, and stakeholder engagement that exposes you to expertise, people, and connections across a broad part of your company. It is a position that requires a multifaceted leadership challenge requiring excellent communication, critical thinking, organization, and time management.

Here are some tips as guidance not as an exhaustive manual, but as a framework of fundamental principles to develop.

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1. Cultivate the Skill of Active Listening

In the nascent stages of your project management career, the inclination may be to demonstrate comprehensive knowledge. I urge you to temper this impulse and instead cultivate the discipline of active listening.

• Engage with your team: Seek to understand their proficiencies, concerns, and motivations. Your team members represent your most invaluable resource.
• Consult with your stakeholders: Discern their underlying needs and strategic objectives, beyond their explicit requirements. What are their critical success factors and prevailing challenges for the project?
• Trust your informed intuition: While data analysis is paramount, recognize that accumulated experience often informs a subtle, yet powerful, intuitive understanding. Acknowledge and integrate this insight.

Active listening is foundational to building trust, identifying latent risks, and uncovering opportunities that might otherwise remain unseen.

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2. Champion Unwavering Clarity

Ambiguity is the primary impediment to project progression. Your imperative is to distill complexity into clear, actionable understanding, ensuring that every participant comprehends the project's purpose, rationale, and their specific contributions.

• Precisely Delineate Scope: Clearly define the inclusions and exclusions of the project's scope. Formalize these parameters and secure unanimous agreement from all pertinent parties.
• Maintain Consistent and Concise Communication: Never presume understanding. Provide regular, succinct updates. Information dissemination should be efficient and devoid of extraneous detail.
• Establish Realistic Expectations: Be transparent regarding timelines, resource availability, and potential impediments. It is prudent to calibrate expectations conservatively to ensure the capacity for exceeding them.

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3. Prioritize Team Empowerment and Nurturing

Your project's success is inextricably linked to the efficacy of your team. As project manager, your paramount responsibility is to empower your team to achieve optimal performance.

• Facilitate and Remove Impediments: Your function is not to execute their tasks, but to eliminate barriers that hinder their progress.
• Delegate Strategically: Place trust in your team members. Grant them both the responsibility and the requisite authority to deliver on their assignments.
• Acknowledge Achievements: Recognize and celebrate both significant milestones and incremental successes. Positive reinforcement sustains morale and fosters continued dedication.
• Provide Constructive Feedback: Offer timely and actionable feedback that contributes to individual and collective development.

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4. Develop Proficiency in Risk Management

Projects inherently involve uncertainty. Unforeseen challenges are not a possibility, but an inevitability. Your role is to proactively anticipate, mitigate, and effectively respond to these eventualities.

• Systematically Identify Risks: Collaborate with your team to identify potential factors that could compromise project objectives.
• Formulate Contingency Plans: For each identified risk, develop a corresponding response strategy. Establish alternative courses of action.
• Maintain Equanimity in Adversity: When a risk materializes, respond with composure. Refer to your pre-established plans, communicate the situation transparently, and collaborate with your team to formulate and implement solutions.

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5. Embrace Adaptability as a Core Competency

The meticulously crafted project plan you develop at inception will almost certainly undergo revisions. Stakeholder priorities may evolve, unforeseen challenges will arise, and new opportunities may present themselves.

• Cultivate Flexibility: Do not cling rigidly to initial plans. Be prepared to adjust your approach as circumstances dictate.
• Extract Lessons from Every Experience: Both triumphs and setbacks offer valuable learning opportunities. Systematically review outcomes to identify areas of strength and areas requiring improvement.
• View Change as an Opportunity: Frame changes not as disruptive forces, but as opportunities to refine and enhance project outcomes.

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The trajectory of a project manager is one of continuous professional development. You will encounter challenges, celebrate successes, and evolve significantly with each project undertaken. Embrace this dynamic process, place your trust in your team, and maintain a strategic perspective. Project management can be an extremely rewarding career nurturing continuous learning.

When Building or Strengthening a Team

 Define your Mutual Purpose:

• Clarify your MISSION: What positive impact do you want to make in the world around you?
• Clarify your VISION: From where you are now, where do you envision you need to be in the future?

Identify your Prioritized Aligned Activities (your Strategy):

• Determine the Strategic Objectives that need to be achieved to make your VISION a reality.
• List the activities needed to achieve each Strategic Objective.
• Challenge the list: Are these the right activities? Are there other paths to achieve each Strategic Objective?
• Align and Prioritize the activities based on your TIME, MONEY, PEOPLE, and RESOURCE constraints.
• Does the set of activities have FOCUS or are some distracting, unnecessary, or weakening the others?
• Where do the activities FIT together in ways they can strengthen and support each other?
• What TRADE OFFS do you need to make by prioritizing some activities over others and are there activities that should not or are unable to be done or would be negatively impacted if certain activities are prioritized (i.e., consider opportunity costs and competing activities)?
• Which activities sustain the others (e.g., billing/accounting, marketing, IT support, front desk, etc.)?
• Which activities should be done first or in a particular order? Which ones benefit by being done later?
• Which activities are the most important and need to be prioritized when allocating TIME, MONEY, PEOPLE, and RESOURCES?

IMPORTANT: Without clear, well-thought-out objectives along with activity alignment and prioritization with FOCUS, FIT, and TRADE OFFS, your list of activities is simply a “to do list” of work and not a good strategy. Work may get done but may not get you to where you want to go.

Clarify your Roles

• Clarify your RACI Roles for the activities:
  • Who is Responsible, Accountable, Consulted, and Informed for each activity’s work progress, issue resolution, status updates, and completion?
• Clarify the DCI Roles for when activities need decisions:
  • Who is the Decider, who is Consulted and who is Informed when making a decision?

Obtain and utilize the Right STEPPPS to complete each activity:

• SKILLS: need the right skills for each role and activity; get training when needed
• TOOLS: need the right tools; these are the things that make work easier (e.g., templates, software, etc.)
• EQUIPMENT: need the right equipment; these are the physical goods required for the work
• PEOPLE: need the right people in each role and activity; hire only when needed and only those aligned with your mission, vision, and values
• POLICIES: need the right policies and rules; document them for clarity and consistency
• PROCEDURES: need the right procedures; document them for clarity and consistency; checklists can be helpful
• SYSTEMS: need the right systems for monitoring and controlling the activities; identify risks/issues early, adjust if needed

Clarify your ways of working to gain and maintain Mutual Trust and Respect

Clarify your core VALUES: This should not be a list of platitudes or words that are selected to sound good. These core values are the key ingredients you feel that make you who you are as individuals and as teammates.

Clarify your ways of working together.

Adhere to and find ways to increase the things that are known to build Trust and Respect:

• Be Ethical
• Be Kind
• Build your Competency
• Be Reliable
• Be true to your Mission, Vision, and Values of your Mutual Purpose

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Understanding ICH M7 Impurity Classifications: An Overview

 The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) sets global standards to ensure that pharmaceutical products meet quality, safety, and efficacy requirements. Among these guidelines, ICH M7 focuses on the assessment and control of DNA-reactive (mutagenic) impurities in pharmaceuticals. These impurities pose a potential risk of inducing carcinogenicity. The guideline provides a framework for evaluating these impurities, determining acceptable limits, and minimizing patient exposure.

One of the critical aspects of ICH M7 is its classification system, which helps categorize impurities based on the available data and the level of concern regarding their mutagenic potential. Understanding these impurity classifications is essential for developing robust risk management strategies.

ICH M7 Impurity Classifications

The ICH M7 guideline outlines five distinct classes of impurities. Each class represents a different level of concern related to mutagenicity and requires different approaches for risk assessment and control.

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Class 1: Known Mutagenic Carcinogens

Definition: Impurities in this class have strong evidence of being mutagenic and carcinogenic in humans.

• Data Source: Class 1 impurities are typically well-documented in scientific literature, regulatory databases, or human studies.
• Risk: High. These impurities pose a significant carcinogenic risk due to their confirmed mutagenicity.
• Action: Impurities in this class must be eliminated or controlled to an extremely low level using stringent risk minimization strategies. If found, they generally trigger immediate regulatory concern and can halt product development until resolved.

Example: Aflatoxin B1, a known mutagenic carcinogen, often falls into this class.

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Class 2: Mutagenic, Not Confirmed Carcinogens

Definition: These impurities are mutagenic in vitro or in vivo but lack sufficient evidence to confirm their carcinogenicity in humans or animals.

• Data Source: Class 2 impurities are identified through positive genotoxicity assays (such as the Ames test) but have no conclusive carcinogenicity data.
• Risk: Moderate to high. These impurities require careful control due to their mutagenic potential, even if carcinogenicity is not confirmed.
• Action: Control is necessary, typically by setting acceptable exposure limits. The default approach is to control them to levels that limit patient risk to a lifetime excess cancer risk of 1 in 100,000, unless further data suggests a lower risk.

Example: Certain alkyl halides may exhibit mutagenic activity but lack definitive evidence of being carcinogens in humans.

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Class 3: No Mutagenic Concern Based on Structure

Definition: Impurities in this class do not present a mutagenic concern based on structural alerts or other data.

• Data Source: These impurities have undergone a robust assessment, often involving (Q)SAR (Quantitative Structure-Activity Relationship) analysis and negative results from genotoxicity testing.
• Risk: Low. There is no significant concern regarding mutagenicity.
• Action: While mutagenic control measures are unnecessary, normal process impurity control mechanisms should still be in place to limit overall exposure to these compounds.

Example: Common excipients that have been thoroughly evaluated and found to lack structural mutagenic alerts.

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Class 4: Non-Mutagenic Based on Available Data

Definition: Impurities in Class 4 have undergone testing, and there is sufficient experimental evidence to conclude they are non-mutagenic.

• Data Source: These impurities have negative results from well-conducted genotoxicity studies (both in vitro and in vivo).
• Risk: Minimal. There is strong evidence indicating that the impurity is not mutagenic.
• Action: Control is based on standard impurity control practices, not on mutagenicity concerns. There are no special requirements under ICH M7 for these compounds.

Example: Compounds that have been tested using a full genotoxicity panel with consistently negative results.

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Class 5: Insufficient Data to Assess Mutagenicity

Definition: Class 5 impurities are those for which there is inadequate data to assess mutagenic potential.

• Data Source: Typically, these impurities lack comprehensive testing data, such as genotoxicity assays or (Q)SAR results.
• Risk: Uncertain. Without data, it's difficult to determine the potential risk, so a conservative approach is often taken.
• Action: In the absence of sufficient data, companies must conduct further testing or, if possible, assume mutagenic potential until data disproves it. A temporary control strategy may be applied, where the impurity is controlled to low levels until testing results become available.

Example: New process impurities or degradation products identified late in development without complete toxicological data.

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Practical Implementation of ICH M7

To comply with ICH M7, pharmaceutical companies must conduct thorough impurity assessments during drug development. This includes:

1. Identifying and characterizing impurities using analytical techniques.
2. Evaluating the mutagenic potential of identified impurities through (Q)SAR analysis and genotoxicity testing.
3. Classifying impurities according to the ICH M7 framework.
4. Establishing acceptable daily intakes (ADIs) and implementing appropriate control strategies based on the impurity class.

The primary goal is to minimize patient exposure to mutagenic impurities, especially those classified as Class 1 and Class 2. For lower-risk classes (3 and 4), standard impurity control strategies suffice.

Conclusion

The ICH M7 classification system is crucial for ensuring the safety of pharmaceuticals by systematically assessing and controlling mutagenic impurities. Each class represents a different level of mutagenic risk, guiding pharmaceutical manufacturers on the appropriate actions to take. Understanding these classifications and applying them properly in drug development minimizes the risk of carcinogenic impurities reaching patients, thereby enhancing drug safety and efficacy.