Treffen Media Presents

2nd Annual
Biowaivers and Bioequivalence Workshop

Understanding the relevance and importance of this topic for the Indian pharma companies, Treffen
Media is organizing the “2 nd Annual Biowaivers and Bioequivalence” Workshop at the Radisson Blu, Hyderabad on the 28 th – 29 th of June 2018.

Workshop introduction

With the USFDA increasing its focus on complex generics and Indian companies looking at these highly lucrative avenues, Indian companies will have to overcome a number of challenges to take advantage of
this position.

In the words of Scott Gottlieb, M.D., Commissioner of Food and Drugs in his recent blog, “Manufacturers of complex generic drugs face a number of challenges in developing their products and demonstrating that their products meet the approval requirements for generic drug applications (abbreviated new drug applications or ANDAs), including establishing that they are bioequivalent to and have the same active ingredient as the brand-name drug.Bioequivalence for complex generic drugs can be challenging with complex drug products that can’t be easily measured in the blood, or when the drug’s therapeutic effect is delivered locally to a particular organ, rather than systemically, through the bloodstream.”

Understanding the relevance and importance of this topic for the Indian pharma companies, Treffen Media is organizing the “2 nd Annual Biowaivers and Bioequivalence” Workshop at the Radisson Blu, Hyderabad on the 28 th – 29 th of June 2018.

Workshop Highlights

  • Rationale – Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System: Guidance for Industry.
  • Biowaivers for complex generics
  • Case studies on special dosage forms‘ drug release/dissolution testing for nanoparticulate suspension.
  • Biowaivers based on IVIVC

Meet the workshop leaders

Dr. Mansoor Khan

Professor and Vice Dean, Presidential Impact Fellow, Texas A&M University, Rangel
College of Pharmacy

  • Served FDA for over 11 years as the Director of Product Quality Research and a Senior
    Biomedical Research Scientist (SBRS) at CDER, USFDA
  • Joined Texas A&M University as Professor and Vice Dean at Rangel College of Pharmacy in
    College Station, TX.
  • He has published over 290 peer-reviewed manuscripts, five texts including “Quality by Design
    for Biopharmaceutical Drug Product Development, 25 book chapters, 250 poster presentations,
    and more than 250 invited presentations world-wide.
  • Held several leadership positions at the American Association of Pharmaceutical Scientists
    (AAPS) including elected chair of pharmaceutics and drug delivery (PDD) and the founding chair
    of formulations design and development (FDD).
  • Served as a FDA representative to EMA (European Medical Agency), WHO, USP, NIH, DoD,
    DARPA, NASA, and Bill and Melinda Gates Foundation.
  • Also served as the science policy advisor to CDER Center Director where he helped resolve
    complex issues of drug reviews and FDA compliance with science.
  • Led the chemistry review team that approved the first 3D printed tablets in August 2015.
  • Received over fifteen FDA/CDER Team Excellence Awards, FDA/CDER Scientific Achievement
    Award, and FDA/CDER Exemplary Performance Awards.

Dr. Jasmina Novakovic

Scientific Leader, Apotex Inc

  • Scientific Leader, Biowaivers & Biocorrelation Group, Apotex Inc, Toronto
  • Panelist at the Modeling and Simulation for Development and Bioequivalence Evaluation of a Generic Drug Product, FDA Public Workshop on Oral Absorption Modelling and Simulation
  • Registered pharmacist in Ontario (Canada), holding PhD degrees in Analytical Chemistry (Charles
    University, Prague) and in Pharmaceutical Chemistry (University of Belgrade).
  • Acts as a subject matter expert in the area of biopharmaceutics and physiologically based PK
    modeling and simulations.
  • Actively contributes to the scientific community by delivering presentations/webinars,
    publishing articles, and reviewing and commenting on regulatory draft guidance documents in
    the area of biopharmaceutics (PBPK modeling, biowaivers). Interacts with regulatory agencies,
    including FDA, Health Canada, EMEA, TGA etc.
  • Member of USP Expert Committee, Chemical Medicines 1.
  • Pharmacist by training, scientist and educator, with 20+ years of experience in the area of
    pharmaceutical research and development in both industrial and academic environments.

Dr. Johannes Krämer

Founder and CEO, PHAST GmbH

  • Currently Elected member of European Directorate for the Quality of Medicines (EDQM) Expert
    Group 12 Dosage Forms
  • Founder and managing director of the “PHAST group” with sites in Germany, France, and
    Switzerland.
  • Qualified Person according to German law and Government investigator for drug testing
  • Elected member of USP Dosage Forms Expert Committee and Expert Panel on Gelatin Capsules
  • Former Elected member of USP Biopharmaceutics Expert Committee and Chair of Ad hoc
    Advisory Panel Performance Test Mucosal
  • Member of the Focus Group on Dissolution/In Vitro Release Performance Testing at
    International Pharmaceutical Federation (FIP)
  • Member of the American Association of Pharmaceutical Scientists, the Biopharmaceutics Group
    within APV (International Association for Pharmaceutical Technology), and the Deutsche
    Pharmazeutische Gesellschaft (DPhG)
  • Co-Editor of book on Pharmaceutical Dissolution Testing and Member of editorial board
    Dissolution Technologies

Dr. Erika Stippler

Director of the Dosage Form Performance Laboratory U.S. Pharmacopeia

  • She was the chair of the Biopharmaceutics Technical Committee of PQRI for several years.
  • Director of the Dosage Form Performance Laboratory at the U.S. Pharmacopeia in Rockville, MD.
  • Between 1998 and 2002, she was the head of Biopharmacy/Stability Testing of Laboratory and Quality Services in Eschborn, Germany.
  • Dr. Stippler has also been Technical Director of PHAST laboratories and Project Manager at Solvias, Switzerland before coming to USP.
  • Her scientific interest is focused on dissolution method development for various dosage forms and on the characterization and standardization of dissolution apparatus and dissolution methods for performance evaluation of pharmaceutical products.
  • She is also an active member of In-vitro Release and Dissolution Testing (IVRDT) focus group of American Association of Pharmaceutical Scientists (AAPS).
  • More than 20 years of experience in the pharmaceutical industry having been at various contract research organizations in Germany and Switzerland and working at USP for 10 years.

Pricing

All Access Delegate Pricing
(includes access to 2 day programme)

Register for the workshop

12 + 12 =

Venue

Radisson Blu, Hyderabad

Address : 8-2- 409 Rd No 6 Banjara Hills 500034 Hyderabad India

https://www.radissonblu.com/en/hotel-hyderabad

Media Partner

Chronicle Pharmabiz – South Asia’s No. 1 Pharma News Weekly and India’s only news based publication catering to the pharmaceutical industry. Pharmabiz is the No. 1 Pharma news weekly in the South Asian markets of India, Bangladesh, Pakistan, Nepal and Sri Lanka. Pharmabiz offers unmatched content in terms of width and depth of coverage related to subjects that influence the dynamics of the South Asian pharma industry. It is also acknowledged for the timeliness and accuracy of its reporting as well as its superior presentation and style.