Programme Structure

Past modules offered in 2009

5536. Good Clinical Practices

This course examines the federal regulatory requirements and processes necessary to conduct valid drug trials on human volunteers. Emphasis is placed on managing the clinical drug study and auditing its processes and generated data. The course also addresses ethical issues and volunteer informed consent.

Both ICH and FDA practices are reviewed throughout this course

• Overview of the history of GCPs
• Informed Consent
• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
• The Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (October 2000)
• The Nuremburg Code
• Institutional Review Boards/Ethics Committees-OAG report (Composition, Function,-Documentation, Monitoring and audit functions)Overview and functions of involved parties
• Site: Investigator, staff, and facilities, Patients, IRB
• Sponsor: Clinical, Regulatory, Quality Control Responsibilities of Sponsors/Monitors
• The Clinical Coordinator
• Clinical monitoring at investigation sites: Set up and initiation visits: Continuing monitoring: Final closeout visit
• Source Data Verification: Site documentation : Document verification : Database lock
• Responsibilities of Investigators
• Responsibilities of IRBs/IECs
• Adverse Events and Safety Reporting
• Monitoring/Bioresearch Monitoring Program
• Source Documentation and Case Report Forms
• Essential Documents
• Protocols, Protocol Amendments, Investigator’s Brochure
• Audits and Inspections
• Fraud and Non-Compliance
• Serious Misconduct/Questionable Data/Scientific Misconduct
• Legal Actions – global response to fraud

 

Date	Day	Week	Time	Topic
15-Aug-09	Sat	1	10am -12pm	Introduction; history of GCPs
22-Aug-09	Sat	2	8am - 10am	Overview of Drug Regulation
29-Aug-09	Sat	3	10am -12pm	Overview of GCPregulation - ICH and FDA perspectives
5-Sep-09	Sat	4	10am -12pm	Protection of HumanSubjects/Informed Consent
12-Sep-09	Sat	5	8am - 10am	Experimental Designsand Conduct of Clinical Trials
10-Sep-09	Sat	6	10am -12pm	Statisticalconsiderations in trial design/data monitoring during trials
26-Sep-09	Sat	7	10am - 12pm	Protocol development,Protocol Amendments, Clinical Holds.
3-Oct-09	Sat	8	10am - 12 pm	Responsibilities ofSponsor and the Investigator/ Safety Reporting
10-Oct-09	Sat	9	8am - 10am	IRBs  (Institutional Review Boards)
17-Oct-09	Sat	10	10am - 12 pm	Clinical trials withspecial populations:  pediatric andgeriatric
24-Oct-09	Sat	11	8am - 10am	Overview ofregulatory submissions (CTD)
31-Oct-09	Sat	12	10am - 12pm	Fraud and Misconductin clinical research
7-Nov-09	Sat	13	8am - 10am	Future of DrugRegulation and GCPs:  review of course
14-Nov-09	Sat	14	Tentative date/time	Exam (phone/Adobe live)
21-Nov-09	Sat	15

 

Instructor: Nancy D. Smith, PhD

Dr. Smith held the position of Director of the Office of Training and Communications (OTCOM), Center for Drug Evaluation and Research (CDER), in the US Food and Drug Administration from 1998 to 2008. As Director of the Office of Training and Communications, Dr. Smith coordinated educational and library resources within CDER, and communication and outreach activities to patients, health professionals, industry, trade press, and the general public. She served on the FDA Task Force evaluating risks of FDA-approved medical products, and is a leader in CDER's effort to expand communication to consumers and health professionals promoting the safe use of medicines. Dr. Smith received her PhD in Applied Mathematics and Statistics from the University of Maryland in 1987 and joined the Office of Biostatistics at CDER that year. She served there as Statistical Reviewer, Group Leader, and later Division Director of the Division of Biometrics II. She chaired the Good Review Practices Initiative that developed and implemented CDER's New Reviewer Training curriculum. Dr. Smith is Chairman of the Biopharmaceutical Section of the American Statistical Association, and serves on the boards of the Drug Information Association (DIA) and the National Council for Patient Information and Education (NCPIE). She is also a member of the International Biometrics Society and the Caucus for Women in Statistics.

 

The GCP course is scheduled to start on Saturday 15 Aug 2009, and to run every Saturday morning either 8-10am or 10-12pm. Exact time table and topics to be offered each week will be updated soon.

Closing date for application is 31st July 09.

 

Compulsory books required to be purchased by student separately

2008 CFR/ICH GCP Reference Guide
Order from www.barnettinternational.com. Students may use the 2005/06 version.

 

PR5301, Food and Drug Laws

This course examines the governance of intrastate and interstate commerce in foods, drugs, cosmetics and medical devices and the effects of the Federal Food, Drug and Cosmetic Act upon research, manufacture, marketing and distribution of drugs.

The Food and Drug Law I module is also one of the 3 SAGE modules that counts toward the NUS Masters in Pharmaceutical Sciences and Technology. Students who intend to pursue the Msc(PST) later but are not ready to sign up into the Masters programme yet, may sign up for this individual module first before signing up for the full Masters programme.

The Food and Drug Law I module will run every Saturday morning, starting on 15 Aug 09, to end around lateNov 09. The exact time table, and more information on the module will be updated at a nearer date.

 

Date	Day	Week	Time	Topic	Format
15-Aug-09	Sat	1	8am - 10am	Overview US legal system. Intro tocases and the FDCA (Food, Drug, & Cosmetic Act).	Live
22-Aug-09	Sat	2	10am -12pm	Historical backgroundof FDCA; intro to product liability	Tape
29-Aug-09	Sat	3	8am - 10am	Cases and materialsdealing with statutory definitions and a discussion of FDCA pre-emptionissues.	Live
5-Sep-09	Sat	4	8am - 10am	Legal issuesassociated with NDA process	Tape
12-Sep-09	Sat	5	10am -12pm	Discussion of ConsentDecrees	Tape
10-Sep-09	Sat	6	8am - 10am	Cases and materialsassociated with NDAs and product definitions.	Live
26-Sep-09	Sat	7	8am - 10am	Factory inspections-- associated issues and cases. Take-home midterm.	Live or tape
3-Oct-09	Sat	8	8am - 10am	Cases and materialsassociated with seizures and injunctions	Live*
10-Oct-09	Sat	9	10am - 12pm	Advertising andpromotional issues aassociated with Rx and OTC drugs and medical devices	Tape
17-Oct-09	Sat	10	8am - 10am	Waxman-Hatch andgeneric drug issues	Live*
24-Oct-09	Sat	11	10am - 12pm	Patents, trademarks,and copyrights	Tape
31-Oct-09	Sat	12	8am - 10am	Cases and materialsassociated with criminal actions	Live*
7-Nov-09	Sat	13	10am - 12 pm	Discussion of recentWarning Letters relating to drugs, devices, and biologics	Tape
14-Nov-09	Sat	14	8am - 10am	Discussion of recentguidances and pending legislation that could impact drugs, devices, orbiologics	Live*
21-Nov-09	Sat	15	8am - 10am	EXAM	phone/live*

 

Instructor:

Barry A. Berger, JD, MBA

Barry A. Berger is an attorney at GlaxoSmithKline with over 25 years of experience in multinational and start-up settings in the pharmaceutical and biotech industries.  Prior to GlaxoSmithKline, Mr. Berger served in senior positions with Aventis (Rhone-Poulenc Rorer), Praxis Biologics, Bausch & Lomb, and Schering-Plough in areas including food and drug law, mergers and licensing, management of complex litigation, and training and development on corporate compliance and preventive law.  Mr. Berger holds a JD from Temple University (Philadelphia, PA), an MBA in Management from Rutgers University (Newark, New Jersey) and a BA from City College of New York.  He is the author of numerous legal articles.  He has participated in professional training seminars and also in the Executive Management Program at Dartmouth College (New Hampshire).  He is admitted to practice in New Jersey, New York, and Pennsylvania.  He has taught for the QA/RA graduate program for over a decade including, Food and Drug Law I, Advanced Topics in Food and Drug Law, and Current Issues in the Pharmaceutical and Medical Device Industries.

 

Compulsory books required to be purchased by student separately

a) Food and Drug Law:  Cases and Materials, 3rd ed, 2007. Hutt, et al, Foundation Press, (ISBN: 978-1-58778-068-4).  
b) "FDLI Statutory Supplement" (Order from www.fdli.org.)
FDCA Statutory Supplement, including FDA Amendments Act and Related Sections of Additional Statutes by FDLI, ISBN: 978-1-935065-01-2

 

Unit Operations

This course will expose students to the current process steps common to the manufacture of modern pharmaceuticals.  In particular, the key variables for each step of a process will be discussed.  Each class will feature a specific process common to pharmaceutical processing. Specific variables will be discussed, including an analysis of each process. 

At the end of the course the student should be able to:
1.  Describe a process by a series of smaller operations;
2.  Describe the key variables for each small operation;
3.  Identify key limitations of time and resources in proposed processes;
4.  Provide constructive improvements to complex processes.
Topics include: Mixing efficiency, filtration efficiency and effectiveness, elastic, plastic and brittle fracture during compaction, particle size reduction, heat flow, humidification and dehumidification, granulation, lyophilization, and sterilization.

 

Date	Day	Time	Week	Topic	Format
13-Aug-09	Thurs	7.30pm - 9.30pm	1	Syllabus,Expectations, Definitions	Live
20-Aug-09	Thurs	7.30pm - 9.30pm	2	Specificationsand risk assessment	Video
27-Aug-09	Thurs	7.30pm - 9.30pm	3	Mixing andDrying	Video
3-Sep-09	Thurs	7.30pm - 9.30pm	4	Granulation andMilling	Video
10-Sep-09	Thurs	7.30pm - 9.30pm	5	Tableting andCapsule Filling	Video
17-Sep-09	Thurs	7.30pm - 9.30pm	6	Mid-term Review	Live
24-Sep-09	Thurs	7.30pm - 9.30pm	7	Mid-TermExamination	Exam
1-Oct-09	Thurs	7.30pm - 9.30pm	8	Coating	Video
8-Oct-09	Thurs	7.30pm - 9.30pm	9	SterilizationMethods	Video
15-Oct-09	Thurs	7.30pm - 9.30pm	10	Lyophilization	Video
22-Oct-09	Thurs	7.30pm - 9.30pm	11	ProcessingReview	Live
29-Oct-09	Thurs	8pm - 10pm	12	Liquid andsemisolids processing	Video
5-Nov-09	Thurs	8pm - 10pm	13	Facilities andSafety	Video
12-Nov-09	Thurs	8pm - 10pm	14	Course Review	Live
19-Nov-09	Thurs	8pm - 10pm	15	FinalExamination	Exam

 

David B. Lebo, RPh, PhD

David Lebo is the Director of cGMP Services at the Temple University School of Pharmacy in Philadelphia, Pennsylvania.  This facility, located at the School of Pharmacy, was designed by Dr. Lebo and manufactures clinical supplies, including placebos.  Dr. Lebo has 10 years industrial pharmacy experience.  His former employers include Johnson and Johnson, Wyeth and FMC.  Dr.  Lebo's expertise is in formulation development, process development and analysis of production feasibility.  His research interests include drug excipient interactions and drug delivery of topical and transdermal products.  He has a BS in Pharmacy and PhD in Pharmaceutics from the Philadelphia College of Pharmacy and Science (now known as the University of the Sciences in Philadelphia).

Closing date for application is 31st July 09.

 

Compulsory books required to be purchased by student separately

Pharmaceutical Process Engineering, Anthony J. Hickey.