APIs & Excipients – A Global Regulatory Overview

Wednesday, September 20, 2017 - 11:00am to 1:00pm
Thursday, September 21, 2017 - 11:00am to 1:00pm

Not sure if your company is a member of IPEC-Americas? See the Member Companies page.

Regulations for ingredients in drug products in some parts of the world are often not well known or can be confusing.  Some countries do not differentiate the ingredients from the drug product (DP), while others may have regulations specific to them. This webinar will provide an overview of regulatory requirements and processes, and in some cases, the challenges they bring, for excipients and APIs in regions outside the US such as Canada, the EU, China, India, Japan, Latin America (Brazil, Argentina, Mexico), Korea and Taiwan.

Presentation Objectives

After completion of this webinar you should be able to:

  • Locate and identify resources (regulatory agencies, laws, regulations, guidance, etc.) within in each region/country* to define what is needed
  • Describe the process of determining what applies to API, and excipients for each region / country
  • Describe the process of applying learnings above to your business/company
  • Describe the process of addressing questions / challenges to regulations in a region / country

*Regions/countries discussed include Argentina, Brazil, Canada, China, the EU, India, Japan, Korea, Mexico, and Taiwan

What Makes this Training Unique

This Webinar is recommended for employees of pharmaceutical companies and excipient makers/distributors – regulatory affairs professionals and other interested parties who want to know more about the similarities and differences between APIs and excipients in regions outside the US.

Learning Objectives

Download the full program, including Learning Objectives for this course.

Accreditations/Recertifications for this Course
The Center for Professional Advancement has been approved as an Accredited Provider by the International Association for Continuing Education and Training (IACET), 11130 Sunrise Valley Drive, Suite 350, Reston, VA 20190. In obtaining this approval, The Center for Professional Advancement has demonstrated that it complies with the ANSI/IACET Standards which are widely recognized as standards of good practice internationally. The Center for Professional Advancement is therefore authorized to offer IACET CEUs for its programs that qualify under the ANSI/IACET Standards. CEU will be awarded for participation in The Center for Professional Advancement’s courses at the rate of .1 CEU per contact hour. CEU will be awarded only upon successful completion of the entire course and 70% accuracy in the required Learners’ Assessment. This course offers a total of 1.5 contact hours or .2 CEUs (CEUs rounded up). 

 

Presenter(s)

Priscilla Zawislak

Global Regulatory Affairs Advocacy Manager
The Dow Chemical Company

Ms. Zawislak has over 30 years’ experience in Regulatory Affairs and Quality functions.  Currently with The Dow Chemical Company, Priscilla is the Global Regulatory Affairs Advocacy Manager for Dow’s Food, Pharma and Medical Solutions business.  Priscilla is the current Chair of IPEC-Americas and has been an active member of IPEC Americas committees since 2001 and is a member of the IPEC Americas Executive Committee.  She is also the Vice-President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India.  Priscilla has also participated for over 10 years in the International Food Additives Council and OFCA, a trade association for cellulose derivatives. Priscilla earned her Bachelor degrees in Biological Sciences and Chemistry from the University of Delaware.

Richard G. Einig, Ph.D.

RAC, CQA, Pharmaceutical Quality Assurance Consultant
CfPA

Richard G. Einig, Ph.D., RAC, CQA is a consultant specializing in the pharmaceutical and veterinary medicine industries. His experience spans over twenty years in senior management of quality, regulatory, and development units of large international companies and start-up “biotechs”. He has worked internationally with innovator and generic dosage form companies, medical device manufacturers and research organizations. Dr. Einig participated in developing the PhRMA Bulk Pharmaceutical Committee’s Guidance on Production of Drug Substance, and is an invited speaker at domestic and international meetings on quality and processing of pharmaceutical products. Dr. Einig is a member of the American Chemical Society as well as a member and carries certifications from the American Society for Quality, the Regulatory Affairs Professional Society, and the Institute for Independent Business. He received undergraduate and graduate degrees in Chemistry from St. Louis University, MBA from Webster University, and Ph.D. from Missouri University. 

Cancellation Policy

Note: No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you are unable to attend the webinar, a recording of the webinar will be provided to all registered persons.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3449 or email ipecamer@ipecamericas.org