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2019 Pharmacopoeia

Understanding Pharmacopoeias

May 15, 2019
Geneva, Switzerland

New training course

  • Education
  • Europe

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Overview

This one-day training course provides a basic understanding of the various pharmacopoeias governing the international pharmaceutical industry. It will familiarize participants and provides a basic understanding of the how the United States, European, Japanese and Chinese Pharmacopoeia work and how to interpret their monographs. The course will also help attendees to understand the importance of ensuring compliance with pharmacopoeial requirements. The information provided is widely applicable to the global biotechnology and pharmaceutical industry that includes innovator, generic and over the counter healthcare manufacturers.

Agenda

  • Wednesday, 15 May 2019

    9:00
    Welcome & Introduction

    • Gathering expectations of participants

    9:30
    Introduction into Ph. Eur., USP, JP and ChP

    • Purpose
    • Legal recognition and applicability
    • Relationship to
      • Marketed medicines
      • Drug development
      • Drug submission
      • National and international inspections
      • Expected impact of EU-US Mutual Recognition Agreement
    • Highlight key differences of Ph. Eur., USP and JP to other important global pharmacopeias (CP, India, Brazil)
      • Public notice
      • Commenting processes
    • Situation of BP after Brexit

    10:30
    Coffee Break

    11:00
    How to Use Pharmacopoeias

    • Structure and text hierarchy
      • General Notices
      • General Chapters
      • General monographs
      • Drug product and substance monographs
    • How to use and apply pharmacopoeias
    • Required versus informational text
    • Highlight key differences in product scope
      • CP: containing TCM
      • USP: containing dietary supplements

    11:45
    Interactive Exercise 1


    12:15
    Lunch Break


    13:15
    Substances and Raw Materials

    • Discuss for Ph. Eur., USP and JP about
      • Organic impurities
      • Excipients
    • Brief introduction into CEPs of Ph. Eur.

    14:00
    Reference Standards

    • Overview into the available compendial reference standards
    • Proper use of compendial reference standards
    • Brief introduction into manufacturing and characterization of secondary reference standards
    • Lifecycle aspect of reference standard

    14:45
    Interactive Exercise 2


    15:30
    Coffee Break

    15:45
    Multiple Choice Test for Attendees


    16:15
    Discussion of Questionnaire and Presentation of Correct Answers


    16:45
    Wrap-up


    17:00
    End of Training Course

Trainers

Susan Schniepp
Susan Schniepp
Regulatory Compliance Associates Inc.
Janeen Skutnik-Wilkinson
Janeen Skutnik-Wilkinson
Biogen

Additional Information

  • Learning Objectives

    Learning Objectives

    The participants

    • Have understood concept of different pharmacopoeias
    • Have understood differences, purpose and relationship of Monographs, General Notices, General Chapters and General Information
    • Have understood the concept of reference standards and how to use them
    • Apply lifecycle management for reference standards
    • Introduce/improve compendial compliance program
  • Who Should Attend

    Who Should Attend

    • QC Manager
    • Laboratory supervisors
    • QA Manager
    • Validation/Qualification personnel
    • Process Developers
    • Regulatory Affairs
    • R&D personnel
  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Crowne Plaza Geneva

Avenue Louis-Casaï 75/77
Geneva, Switzerland
Phone: +41 (0) 22 710 30 29

Make a Reservation
Crowne Plaza Geneva
  • Accommodations

    Hotel Website

    Renovated and re-designed in 2014, the Crowne Plaza Geneva is within a 3-minute drive of Geneva Airport and the Palexpo Exhibition Center, and only a 10-minute drive from the city center. The hotel offers a free shuttle service from and to the airport.

    The hotel, with a Club floor on the top floor, offering panoramic views of the surroundings also offers its guests a complimentary breakfast, refreshments, snacks and a large selection of newspapers and books.

    A bus stop and a taxi stand are right in front of the hotel. A free card for public transport is available at the reception. The hotel is only a 4-minute drive from the Balexert, Geneva's largest shopping mall.

    PDA Europe has reserved a limited number of rooms until the 5th April 2019.
    Book Your Room for the PDA Group Rate

    Single Room CHF 235 per night, VAT, Taxes and Service Charges will apply*
    Double Room CHF 265 per night, VAT, Taxes and Service Charges will apply*

    *Rates are per room and night, including the following:
    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
  • Amenities

How to Get Here

By Air

Nearest Airport: Geneva Airport - GVA, known as Cointrin Airport
Airport Phone:
+41 22 717 71 11

By Car

1.4 km, 3 min by car. The Crowne Plaza Geneva is located at Avenue Louis Casai 75-77, Geneva 1216.

Other Options

Free shuttle bus between airport and hotel.

Train station: Cointrin.

Subway station: De Joinville bus stop.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €895

All fees given in Euro and excluding VAT (21%)

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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Contact

Program Inquiries
Exhibition Inquiries
  • Nadjeschda Gomez-Stahl
    Manager, Exhibition & Sponsorship

    gomez@pda.org

Training Course Inquiries

Tel: +1 (301) 656-5900
TRI@pda.org

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

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