In the pharmaceutical industry, formulation scientists are very well educated and experienced according to their merit in the dosage form design to include formulation development, method of analysis, kinetics and stability… etc ensuring compliance with the guideline requirements covering module 3 of the CTD.
However, the clinical side concerning the bioavailability/bioequivalence studies covered in Module 5 of the dossier are usually designed and carried out by a different team of clinical background and experience. The clinical team might not be directly involved in the dosage form design from start and have not gained sufficient experience to positively contribute in the studies covering formulation factors effecting the bioavailability performance of the finished product.
This difference in the background and experience or even orientation between the two different teams within the same pharmaceutical establishment have created a gap in understanding each sides requirements and limitations.
Interestingly this difference and the gap identified in the understanding of the requirements of the quality of the finished product and its design linked to the bioavailability/bioequivalence performance have been relatively demonstrated to a certain extent in the guidelines published and their main scope.
For example, concerning modified release products, two different guidelines have been recently published by EMA with different scopes. One is covering the quality side (Guideline on quality of oral modified release products, EMA/CHMP/QWP/428693/2013published in March 2014)
Whilst the other is covering pharmacokinetics and clinical evaluation of modified release dosage forms (EMA/CPMP/EWP/280/96 Corr1) published November 2014:


The aim of this workshop is an attempt to fill this gap by linking the quality of the concerned dosage form expressed in terms of dissolution behaviour with its bioavailability/bioequivalence performance required by the guidance.
Two case studies will be presented when the competent authority in EU had intervened requesting further information to justify the biowaiver claim made.

Masterclass LEADER


Muhaned Al-Hindawi

Managing Director & Principal Consultant , Ontarget pharma Consultancy

Dr Muhaned Al-hindawi The managing director and principal
consultant of “Ontargetpharma Consultancy”, London UK.
Worked as a Senior Pharmaceutical Assessor with MHRA.
During work in MHRA made a number of break-through issues.
Among those are: The dissolution performance of multiplestrengths
of oral solid dosage forms and how biowaiver can
be applied and effect of excipient on the bioavailability of API from oral
solution and biowaiver criteria. Occupied a number of technical posts in
the pharmaceutical industry with over 15 years of hand on experience in
many areas. This includes new product development, method of analysis
construction and process validation. Involved in a number of high profi le
projects including a joint project between Jordan and EU, upgrading the
Jordanian pharmaceutical manufacturing companies to comply with the
European standards and levels. Prior to joining the pharmaceutical industry,
worked in a number of research and academic institutions whereby a
number of publications have been made

Ontarget pharma Consultancy

Ontarget pharma Consultancy is a leading pharmaceutical consulting company based in London, UK. The aim is to provide a high standard of pharmaceutical consultancy covering the areas of regulatory affairs and technical requirements governed by the current Directives and guidance for marketing authorisation of medicinal products in UK and rest of EU.
Detail of the services provided can be seen by browsing the company’s website www.ontargetpharma.com

Masterclass programme

8:30 Registration & Coffee

9:00 Critical review of guidance on the quality and bioequivalence of immediate release preparations.

Muhaned  Al-Hindawi

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy
View Bio

11:30 Morning Coffee

11:50 Critical review of guidance on the quality and bioequivalence of prolonged release products.

Muhaned  Al-Hindawi

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy
View Bio

12:30 Critical review of guidance on the quality and bioequivalence of gastro-resistant products

Muhaned  Al-Hindawi

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy
View Bio

13:00 Networking Lunch

14:00 Two case studies in which the competent authority in EU had intervened requesting further information to justify the biowaiver request made:

Muhaned  Al-Hindawi

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy
View Bio

-Effect of excipient on the bioavailability of the API from aqueous oral solution and biowaiver criteria
-Composition proportionality & dissolution similarity of multiple strengths formulations of oral solid dosage forms

15:00 Afternoon Tea

15:20 Panel Discussion

Muhaned  Al-Hindawi

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy
View Bio

16:00 Closing remarks

Muhaned  Al-Hindawi

Muhaned Al-Hindawi, Managing Director & Principal Consultant , Ontarget pharma Consultancy
View Bio

16:30 End of workshop



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CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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