General Courses

Project Management
Participants practice both the hard and soft skills of project managers on real projects selected from attendees. Throughout the course, the class develops these projects while practicing their managing skills.

Technical Writing
Participants are instructed in the basics of clear, concise technical writing. Throughout both sessions, instruction is interspersed with exercises designed to practice writing skills. Session one ends with each participant drafting a short technical piece. These drafts are returned to the participant at the beginning of session two with personalized comments.

Time Management
In this single session course, participants learn to identify their unique business objectives. They also practice the skills needed to manage their time in a way that achieves those objectives effectively.

Negotiation Skills
The participants learn the techniques of successful negotiation. The techniques are practiced in breakout sessions using example situations to give hands-on experience.

Conflict Resolution
The participants will learn techniques to resolve conflicts with team members, management, and external partners without damaging relationships. Skills will be practiced in the classroom using role play on case studies.

Regulatory Courses

US Regulatory Affairs (Part I: The IND Phase; Part II: The CTD/NDA Phase)
The participants in this course will learn the background of the IND and NDA and will receive training in how to prepare for FDA meetings and the applications for submission to the FDA.

Canadian Regulatory Affairs (Part I: The CTA Phase; Part II: The NDS Phase)
The participants of this course will receive an overview of Canadian regulatory affairs, with an in-depth understanding of the clinical trial phase, registration and the post-approval phase.

European Regulatory Affairs
The participants in this course will receive a comprehensive overview of the development of the registration systems available for approval of products in the European Union (EU). There will also be a review of Centralized, Mutual Recognition, and National Registration procedure and a familiarization with EMEA policies and procedures.

Japan – Overview of Regulatory Processes and Requirements
The participants in this course will receive a comprehensive overview of the regulatory affairs processes and requirements in Japan. This will include an in depth look at chemistry and pharmacy aspects of development. Also, recent changes in the MHLW structure and review process will be discussed.

Regulatory Affairs in ROW (Latin America, Eastern Europe, Pacific Rim and Middle East/Africa) – Clinical Trial and Registration Phases
The participants in this course will receive a general overview of regulatory affairs in ROW. In addition, strategic regulatory considerations will be reviewed, including a regional area focus on similarities and differences in the above mentioned countries.

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Preparing the CMC sections of global submissions using the Common Technical Document (CTD) - Practical Implementation
The participants in this course will learn the steps to be followed when preparing the CMC section of global submission in the format of the Common Technical Document.

Chemistry, Manufacturing and Controls (CMC) - Regulatory Challenges and Strategies
The participants in this course will review various strategies for overcoming common regulatory challenges faced in CMC submissions. Various case studies will be presented.

Drug Substance Challenges - A Scientific and Regulatory Overview
The participants in this course will receive and in-depth analysis of the challenges presented from a scientific and regulatory perspective for the development and registration of a drub substance.

Drug Product Challenges– A Scientific and Regulatory Overview
The participants of this course will receive an in-depth analysis of the challenges presented from a scientific and regulatory perspective for the development and commercialization of drug products.

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Analytical Methods and Specifications
The participants in this course will review analytical techniques and terminology to address method validation requirements at all stages of the drug development process.

Analytical Validation for Drug Substance and Drug Product (what is acceptable during development for Phases I-III)
The participants of this course will learn the extent of analytical validation requirements as the drug moves through Phases I through III. The focus moves from safety during the early stages to safety and efficacy during intermediate stages and finally to robustness and transferability during final stages.

Analytical Dos and Don’ts
The participants in the course will review critical techniques for delivering reproducible data and methods. Emphasis will be on good analytical practices as well as tips for what FDA reviewers look for in analytical methods.

Regulatory Strategies for Successful Management of CMC Changes during development and Post-Approval Phases
The participants of this course will be instructed in how to implement strategies and effect the successful management of CMC changes during development and approval.

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Post- Approval CMC Changes (including SUPAC), How to Keep Product on the Market
The participants of this course will receive an in-depth review of post-approval CMC changes, including SUPAC, and how to keep the product on the market.

CMC Life-Cycle Management – A Global Regulatory Perspective
The participants in this course will receive an in depth understanding of the CMC Development and post-approval activities. The challenges and opportunities for effective management of the CMC activities will also be highlighted.

Preparing for Successful FDA & EU Agency Inspections
The participants of this course will receive knowledge of how to successfully pass an agency inspection in the US or EU, how to prepare for an inspection, and the dos and don’ts encountered during an inspection.

Overview of Good Manufacturing Practices (cGMP)
The participants of this course will receive an overview of cGMP and training in how to deal with problems and current issues in the implementation of cGMP.

Overview of Drug Development – A Regulatory Perspective
The participants of this course will receive an overview of drug development, including integration of preclinical, clinical, CMC development, manufacturing, activities and marketing interfaces.

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Current and Future Regulatory Strategies (including ICH/CTD)
The participants of this course will receive an in-depth look at current and future regulatory trends and strategies and how to implement them.

Role of Regulatory Affairs Professional in Product Development, Registration and Life-cycle Management
The participants of this course will receive an in-depth look at the role of the regulatory affairs professional in the arena of drug development.

Contract Manufacturing & Outsourcing Dos & Don’ts - A Regulatory Perspective (Preparation of Clinical Trial Materials & Commercial Supplies)
This course will focus on an array of strategies to improve resource utilization with the goal of improving project performance. Participants will also be provided with real life situations of what to do and what not to do when contracting and outsourcing work.

Regulatory Intelligence - How to be Proactive
The participants of this course will receive an in depth overview of available resources for obtaining global regulatory insight/information and rapidly obtain up-to-date reference materials from various agencies.

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