Orphan Drug History – Development and Overview
Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia &UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.
Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.
In 2019 she opened her own company, McElroy Training, and Consultancy, LLC which provides consultants for various projects as well as on and off-site training to pharmaceutical and biotech companies throughout the United States.
Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams through implementing 5 simple techniques she has learned and applied through the years.
This webinar will discuss the history of Orphan drugs, and how the Orphan drug Act of 1983 has helped manufacturers move forward with developing and producing drugs for rare diseases and conditions.
This webinar will discuss key issues with Orphan drugs such as clinical testing. Attendees will learn what the Orphan Drug Act is and how it has increased the manufacturer's willingness to develop and manufacture drugs and therapeutics for rare conditions.
This webinar will provide an understanding of the incentives for manufacturers to produce Orphan drugs. Case studies of the success of various Orphan Drugs will be discussed as well.
- What is an Orphan Drug?
- Orphan Drug Act of 1983
- Orphan Drug – Key Issues
- Kefauver-Harris Drug Amendment
- Regulatory Incentives
- Effectiveness of the Orphan Drug Act
- Case Studies
- Regulatory Harmonization
Course Level - Intermediate
Who Should Attend
- Research Scientists
- Clinical Professionals
- Quality Assurance professionals
Why Should You Attend
One should attend this webinar to understand what Orphan Drugs are and to learn of the incentives manufacturers now have under the Orphan Drug act of 1983 to manufacture drugs for rare diseases and conditions.
If you are concerned about funding for drugs and therapeutics for rare disease attend this webinar to learn of the incentives for manufacturers and the success rate of these rare drugs.
In the United States Pharmaceutical research depends on both government funding and private investment. The revenue potential of a drug in treating a particular disease can influence for-profit manufacturers' willingness to devote necessary resources to its development. Therefore, if a disease or condition affects a small number of patients and does not allow recovery of the private research investment, then products for that condition may be developed slowly or not at all. Congress passed the Orphan Drug Act in 1983 to provide incentives for industry investment in treatments for such rare conditions.