AAPS/EUFEPS Global Bioequivalence


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Co-sponsored By:

Workshop Summary

For several years now, the European Federation for Pharmaceutical Sciences (EUFEPS), with its Network on Bioavailability and Biopharmaceutics (BABP) in the lead, has worked toward harmonizing the requirements for bioequivalence assessment. This goal was encouraged from the beginning by the European Medicines Agency (EMA) as well as the US Food and Drug Administration (FDA). To support the intended process of global harmonization scientifically, a series of international conferences was started by EUFEPS in collaboration with AAPS. The first one was held in 2015 in Amsterdam/The Netherlands, followed by a second one in 2016 in Rockville/USA, and a third one in 2018 again in Amsterdam. All conferences were characterized by open discussions and constructive exchange between regulatory scientists, academia and industry. Thus, these contributed significantly to the debate on a worldwide harmonization of bioequivalence requirements. Also regulators and speakers from other countries/regions, e.g. Canada, Chile, China, India, Japan, Jordan, Mexico, and Brazil, attended and contributed to the discussions. Such global participation has formed an ideal platform for scientists from the pharmaceutical industry and academia to exchange their experience and views with regulators. Scientific consensus achieved at the end of processes such as these should constitute the most appropriate basis for harmonization.

In order to disseminate the outcomes most widely, conference reports have been compiled. The first two have been published in the European Journal of Pharmaceutical Sciences and the third is in preparation.

Participants of this event will:
  • Receive a summary of the outcome of the sessions from the last conference and have an opportunity to provide input for further harmonization on these topics. This may also include preliminary discussion regarding the definition of a Global Reference Product.
  • Get an overview of the similarity and differences in BE considerations for implants / long-acting injectables across major regulatory agencies, and join the discussions towards, development of similarity in approaches.
  • Find out the current BE requirements for orally inhaled products for major regulatory agencies, and a scientific critique of these from academic and industry experts.
  • Join the discussion regarding the pros and cons of the necessity of fed BE studies for immediate release oral dosage forms with regulatory, industry, and academic scientists.
  • Get an in-depth understanding of how to design complex BE programs that would be viewed positively across all major regulatory regions.
Conference Chairs
Henning Blume, Ph.D., SocraTec C&S
Mehul Mehta, Ph.D., FDA

Scientific Planning Committee

Gerald Beuerle, Ph.D., ratiopharm
Henning Blume, Ph.D., SocraTec C&S,
Angelica Dorantes, Ph.D., FDA
Georg Hempel, Ph.D., University of Münster
Wenlei Jiang, Ph.D., FDA
Andreas Kovar, Ph.D., Sanofi
Mehul Mehta, Ph.D., FDA
Henrike Potthast, Ph.D., BfArM
Gustavo Mendes Lima Santos, Ph.D., ANVISA
Barbara Schug, Ph.D., SocraTec R&D
Anne Seidlitz, Ph.D., University of Greifswald
Nilufer Tampal, Ph.D., FDA
Yu-Chung Tsang, Ph.D., Apotex
Jan Welink, Ph.D., MEB

Registration Information

Registration Type Early Registration
(July 1-Nov 11, 2019) 
On-site Registration
(Nov 12, 2019-On-site)
AAPS/EUFEPS Member $1,095 $1,395
Non-member $1,395 $1,695
Government  $550 $650
Student $150 $250

Registration Fee Includes:

    • Access to the session slides post event
    • Continental Breakfast Daily
    • Buffet lunch Daily
    • Evening Reception 


If you cancel registration on/before, November 26, 2019 you will be refunded your registration fee minus an administration fee of $100 for members/non-members or $50 for students.

No refunds will be given for “no shows” or for cancellations received on or after November 27, 2019.

Refunds will be credited back to the original credit card used for payment, or if paid by check, a refund check will be issued to the original payer within 30 days of submission.


Registration substitutions from the same company may be submitted in writing to [email protected] at any time without penalty. If the membership status of the substitute differs from that of the original registrant, a refund or additional charge at the current rate may apply.

Housing Information


DoubleTree Bethesda now The Bethesdan Hotel, Tapestry by Hilton
8120 Wisconsin Ave 
Bethesda, MD, 20814

A special rate of $159/night is available for a limited number of rooms until November 18, 2019, 5:00 pm EST.

Book your hotel accommodations online or call 1.301.652.2000 and use the reference booking code, GH2.

Driving & Metro Information

Featured Hotel Amenities

  • $15 discounted parking for day and overnight
  • Complimentary in-room Wi-Fi
  • Fitness Room


Approximate distances:
  • 5 miles – Bethesda Metro Station
  • 9 miles - Washington, DC
  • 12 miles - DCA (Ronald Reagan Washington National Airport)
  • 26 miles - IAD (Washington Dulles International Airport)
  • 35 miles - BWI (Baltimore/Washington International Thurgood Marshall Airport)