Industries: Pharma / Biotech

The Drug Development Process from Concept to Market

Course Director: Michael A. Pierro

Course Fee: $2650.00 Regular Registration / $2450.00 Early Bird (30 Days in Advance)

  Accreditation: ***RAPS Approved Course*** 

PharmaTrain Recognized Course    

 

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

The drug development process involves a series of lengthy steps that determine the degree of success for every drug brought to the market. Decisions made throughout the process affect every aspect of future development and impact heavily on commercialization strategies.

Included in the course content is an overview of the regulatory and pre-marketing steps that occur to ensure a successful launch. The course also covers sales planning and the commercialization decisions that affect the development of the drug.

Understanding of the drug development process includes:

  • Basic concepts of drug discovery and testing
  • Scientific, regulatory, and management framework for modern pharmaceutical development
  • Pre-clinical study requirements and how information gathered is used for human clinical studies
  • The four major clinical phases (1-4) in the drug development process and the rationale for each and an introduction to the special problems of each phase
  • The economics of drug development
  • Cost/benefit issues in clinical development
  • Discovery and development milestones
  • The IND Process
  • The NDA Process
  • FDA Interactions – Application review and approval process
  • Patents and exclusivity
  • The rationale of government regulations and how they effect the development process
  • The relationship between the Code of Federal Regulations and ICH GCP
  • Designing optimal clinical trials
  • Drug labeling, marketing, and pharmacoeconomic studies
  • Project management cross functional teams during the development process

Who Should Attend

Designed for employees who need an understanding of the drug development process, this course provides a detailed picture of the complex and highly interrelated activities of the development cycle for drugs and biologics, from discovery to a successful commercialization. The training will be beneficial for anyone involved in the R&D process. It can also be customized for marketing & sales personnel who need to understand that actions taken during the development process have a significant effect on sales and marketing strategies.

Typical attendees include:

  • Research & development scientists
  • Clinical monitors and research associates
  • Medical and clinical investigators and study coordinators
  • Physicians & medical liaisons
  • Statisticians & data management professionals
  • CMC/pharmaceutical research professionals
  • Regulatory affairs professionals
  • Project managers
  • Financial managers
  • Brand team personnel
  • Senior sales managers
  • Strategic planners

A shorter on-site version of this course is available for administrative/support personnel or those new to the life sciences industry who require an understanding of the steps and terminology used in the development process. We can customize the program to meet the specific needs of your personnel.

Course Agenda

First Day

09:00 – 09:30-Welcome

  • Introductions
  • Course Objectives
  • Agenda Review

09:30 – 10:30-Drug Discovery

  • Regulatory definition of a "drug"
  • Types of drugs & how they are produced
  • Approaches to drug discovery
  • Patents
  • Exercise # 1 Drug Discovery

10:30 – 10:45 – Break

10:45 – 12:00-Drug Development

  • Challenges in drug development
  • Drug Development Lifecycle
  • Industry Perspective
  • Non-Clinical Studies
    • GLP
  • Clinical Studies
    • The IND/IMPD
    • CDP
    • Phase I-IV
  • Exercise # 2 Drug Development

12:00 – 01:00-Lunch

01:00 – 03:00-Drug Development (continued)

03:00 – 03:15-Break

03:15 – 05:00-Drug Development (continued)

Second Day

09:00 – 10:00-Good Clinical Practices

  • Purpose & Principals
  • The IRB/IEC
  • Exercise # 3 GCP

10:00 – 10:30-Components of a Clinical Study

  • Regulatory Requirements
    • History & Role
  • Key Players
    • Roles & Responsibilities
  • Documentation
  • Monitoring
  • Data Processing
  • Exercise # 4 Clinical Study

10:30 – 10:45 – Break

10:45 – 12:00-Components of a Clinical Study(continued)

12:00 - 01:00-Lunch

01:00 – 02:30-The NDA/CTD

  • Definition & Contents
  • Process
    • Submission, Review & Approval
  • Exercise # 5 NDA/CTD

02:30 – 02:45-Break

02:45 – 05:00-Post Approval

  • Sales Training
  • Role of Marketing
    • Marketing Strategy
    • Promotional Advertising
  • Post Marketing Compliance
    • AE Reporting
  • Exercise # 6 Post Approval

Third Day

09:00 – 09:45-GMP

  • Impact
  • Commercial Manufacture
  • GMP Controls
  • Scale-up Issues
  • Process Validation
  • Exercise # 7 GMP

09:45 – 10:00-Break

10:00 - 12:00-DDP Workshop

  • Break into working groups
  • Present findings

12:00 – 1:00 - Lunch

1:00 – 02:00 - Course Review

02:00 – 03:00-Wrap-up

  • Final Q&A
  • Course Evaluation

Learning Objectives

This course provides an understanding of the interrelated activities throughout the drug development cycle and is designed for R&D, operations and/or marketing and sales management. This course serves as an introduction to the drug development process and will familiarize participants with the steps involved in developing a drug from Discovery to Commercialization. The course is often customized to address specific organizational, departmental or functional issues.

Testimonials

"Good level of engagement between the instructor and the attendees. The material covered was the right level of depth. We didn’t waste time with industry basics and dove into the next couple of layers of detail which is what I was looking for. I liked the reviews at the end of each chapter as it helped test/reinforce the concepts." Kara K., Transactions Lead, Shire
"The best course I have ever attended as it was exactly what I needed to know. I really enjoyed the course structure and the real life examples." Elena S., Principal Research Assoc., Moderna Therapeutics
"Phenomenal instructor! Very Knowledgeable." David M., Project Manager, Biomarin
"First regulatory course, very well done! The course director used great anecdotes and personal experience that made the material more relatable." Charles C., Research Scientist, Tetra Bio-Pharma
"It was a highly interactive course. I learned a lot, especially in terms of understanding the clinical development procedure." Vinit K., Senior Investigator, Bristol-Myers Squibb
"The Course Director is a very inspiring instructor, with a lot of interesting examples from real life, which really gives an extra dimension to the course." Helle C., Project Coordinator, H. Lundbeck A/S
"The course director was really good at communicating and pacing the training sessions. Even though I did not have any pharma or medical background, I could still easily and comfortably follow the course material." Siew L., Project Information Coordinator, H. Lundbeck A/S
"The Course Director was a very engaging and knowledgeable instructor! I would highly recommend his course on the Drug Development process to others who wish to gain a good understanding of the main concepts for Clinical Trials and Drug Development. I thought the workshop was a great exercise where we were able to combine everything we learned and put it into comprehensive use." Bianca F., Project Coordinator, BioMarin Pharmaceutical
"This was the first training program I attended; I thought the Course Director did a great job. He was very informative on multiple subject matters. He made it easy to pull the big picture together." Megan, Project Coordinator, US WorldMeds
"Excellent job covering various aspects of clinical operations and complexities involved. In general, several of my colleagues commented that this is an excellent training in understanding the overall drug development and involvement of various functions." Ravi R., Director, Forest Labs
"Very much enjoyed the course. It was simple, clear, direct knowledge. OVERALL – it was very refreshing to have a course that was not "soft" on knowledge. I have questions I am going back to my team with!" Sharon B., Global Project Manager, UCB
"Very useful. Helped to fill in the gaps of my previous knowledge." Timothy T., Sr. Research Scientist, Forest Labs
"The Course Instructor was extremely knowledgeable. He made what could be dry course material very engaging and interesting. The course was the right length and the exercise was effective at enforcing the course learnings." James H., Senior Project Manager, Integrated Project Management
"The course was fantastic! The course director shared his vast experience with us and illustrated many topics with real life examples. Thank you!" Pia P., Project Coordinator, Merck Serono
"This course should be mandatory for all professionals who wish to gain a comprehensive understanding of the Pharmaceutical Industry!" Dr. Asher H., Associate Medical Director, Sanofi-Synthelabo
"This is a wonderful course. I always work in a lab and see only a small part of the whole process of drug development. Now I know my "position" in the whole picture. It makes work more meaningful and enjoyable." Fong Z., Senior Scientist, Shire Labs
"This is a very good course that allows one to fully understand the drug development process. ANYONE who works for a pharmaceutical company should attend this course. The knowledge that I gained during this course will help me to assist not only my boss, the president of the company, but also other staff members in the company." Hiromi G., Executive Assistant, Kyowa Pharmaceutical, Inc.
"I will be going back to my organization and recommending that we have this course delivered in-house for the benefit of a wide number of our associates. The Course Director was very knowledgeable and his ability to communicate his expertise in GCPs would complement our clinical efforts. The GMP aspects of drug development will give us a better appreciation of the "big picture" and how one's work fits into the overall process leading up to the approval of the NDA." Ruth M., Assistant Director Pharmaceutical Analysis, Shire Labs.
"I think this course is extremely useful. It provides a good overview of the drug development process, which is very helpful for me to look at in a big picture. The Course Director is very knowledgeable and answered all the questions being asked. I look forward to more courses presented by CfPIE." Wu Y., Sr. Scientist, Allergan
"A very comprehensive overview of the Drug Development Process, and was particularly strong regarding the IND and NDA process." Richard E., Manager, Compliance & Training, Sanofi Pasteur

Frequently Asked Questions

Does this course discuss the differences in the drug development process between the US and Europe?

Yes, the similarities and differences between the US and Europe with respect to how medicinal products are developed and approved are discussed in this course.

Do you cover the pre-clinical and clinical study requirements for development?

This course includes an overview of the global regulatory requirements for conducting pre and post clinical studies in the US and EU. The principals of GLP, GCP and GMP are discussed.

Does this course discuss generic medications?

This course discusses the differences between generic and innovator medicinal products as well as the process for submission and approval for marketing.

Does this course discuss the CDP and cross functional teams?

Yes, this course will discuss the importance of preparing and revising an effective CDP and the role of the cross functional teams in executing the CDP.

RAPS | Regulatory Affairs Professionals Society CfPIE is a Regulatory Affairs Professional Society (RAPS) RA Professional Development provider.

CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.  Click here for the list of courses reviewed and approved by RAPS.