Reflecting on My Journey in Linkedin: Highlights from February to April 2025 🚀

Over the past few months, I’ve been sharing insights into critical areas of:

1. Pharmaceutical regulatoy affairs and development
2. Project managment and organizational excellence.

Here's a quick summary of the topics we explored, along with links for anyone who'd like to revisit or catch up:

Pharmaceutical regulatoy affairs and development

• BE studies resources: Navigating bioequivalence (BE) regulations is tough, but BE monographs are key guides for successful drug development. They offer precise study designs and potential shortcuts to approval.
• Biosimilars: A new report analyzing biosimilar approvals across the FDA, EMA, and SFDA reveals inconsistencies in classification and interchangeability rules. It prompts critical questions about regulatory harmonization, reliance mechanisms, development strategies, and the challenges companies face navigating global requirements.
• Generic product development (Part 1 and Part 2): Bringing a generic drug to market hinges on a solid feasibility study, evaluating technical, regulatory/patent, market, and economic viability. This crucial first step determines if the complex journey of generic development – from research and formulation to bioequivalence studies and commercialization – is worth embarking on.
• API supplier selection: check these recommendations to select your API suppliers.
• Manufacturers approval status: check this post to know how to identify the approval status of any manufacturer.
• Nitrosamines:

*Mastering nitorsamines in 72 hours: Ignoring the nitrosamine issue is a recipe for failure for any pharmaceutical company aiming for global markets. This article offers a quick access point to essential resources for those in regulatory, QA, and R&D roles.

*WHO newlu published guideline: World Health Organization has just published a new guidelines for the prevention and control of nitrosamines in pharmaceutical products👍Give it a read to distill the major issues this guidance brings to the pharm community table of discussion.

*Low-nitrite content excipients: Nitrosamines pose a drug safety threat often stemming from hidden nitrite levels in excipients. Controlling nitrites, especially through low-nitrite excipient grades from reliable suppliers, is crucial. This post will help pharma professionals in formulation, QA/QC, and regulatory affairs to scrutinize excipient origins and nitrite content to safeguard patient health.

*Nitrosamines and BE requirments: FDA offers smart ways to control nitrosamines in generics without full BE studies for some drugs, like using low-dose antioxidants with dissolution data. However, NTI, sublingual, and ODT drugs still need full BE. Strong data supporting any formulation change is key for ANDA and Regulatory Affairs. check this post for more details.

• RAC exam

*My RAC exam experience: Five years ago, the decision to study for the RAC-Drugs exam with RAPS proved challenging yet incredibly fulfilling, with an immeasurable positive impact. Recalling a helpful article written about that experience, it's being shared again to guide and encourage those currently preparing for the upcoming exam.

*EU different areas: Trying to grasp EU regulations for the RAC exam felt like a mind-bending puzzle, leading to the creation of a unique Venn diagram visualization.

• The glyoxal case: Recalling one of my R&D challanges. A stable, colorless drug solution turned orange due to reactive Glyoxal impurity present in a new excipient batch, which was listed in the EP but not controlled in the USP used by the company. This highlighted the need to consider different global pharmacopoeia requirements and thoroughly investigate raw materials beyond standard QC checks.

Project managment and organizational excellence

• Situational leadership: Effective leadership requires adapting your approach based on team members' development levels, aiming to empower them towards independence for maximum productivity.
• Atomic growth: To elevate yourself and your organization, choose between gradual "atomic" growth for long-term sustainable results or impactful "breakthroughs" requiring focused effort. Overcome boredom and persist; "Atomic Habits" is recommended.
• Types of organizations: Tall, hierarchical pharma structures can hinder innovation and slow decisions; flatter structures promote agility and faster progress.
• The Dunning-Kruger effect: the less you know, the more confident you might be, while experts recognize their knowledge gaps. Knowing what you don't know fuels growth.
• The functions of a manager: Effective management requires mastering 7 key functions: Planning, Organizing, Staffing, Directing, Coordinating, Reporting, and Budgeting. These provide a framework to move from chaos to confident leadership.
• Agile in Pharma: Think generic pharma is stuck in rigid processes? Agile methodologies are challenging those norms, promising unprecedented speed and efficiency in drug development now. Check this post for more!
• Project management mind map: New to project management? Here's your learning roadmap! 🗺️ This mind map gives you a clear overview of the key things beginners need to learn, helping you organize your thoughts and focus your efforts.

As we wrap up this series exploring the intricate landscapes of pharmaceutical regulatory affairs and development, alongside the principles of project management and organizational excellence, I trust these insights have been valuable in navigating your professional journey. Whether you're deciphering BE regulations, strategizing biosimilar development, streamlining generic product pipelines, ensuring API quality, tackling nitrosamine challenges, preparing for the RAC exam, or seeking to enhance your leadership and organizational agility, the journey of continuous learning and improvement never ceases.

Now, I'd love to hear from you. Which of these topics resonated most with your current challenges or aspirations? Are there specific areas you'd like to delve deeper into in future discussions? Share your thoughts and let's continue the conversation. Your feedback will help shape future content and ensure it remains relevant and impactful for our community. Let's learn and grow together.