Dr. Mohammed Saleem
|1974-1978||BS degree from Kuwait university-Biochemistry department with general point average of “B+” (80-90%), as biochemistry major/ chemistry minor graduate.|
|1978-1982||PhD degree from Essex University, UK. Thesis Title: Redox and Ligand Binding properties of Haem Proteins.|
|1999-2000||University of London, U.K. Post Graduate Certificate training on Intellectual Property Law.|
- PROJECT MANAGEMENT:
In addition to my daily project management tasks I have supervised and managed teams in which technical and legal matters such as draft proposal for Jordan ministry of health IPR bylaws in drug registration systems. I have conducted on behalf of UNDP extensive program to empower and capacity building of Bahrain industrial property department at ministry of industry and trade in order to comply with TRIPS and USA FTA. WHO used my experience to manage HIV project in Jordan, Kuwait and other Gulf states. Further I have managed World Bank project on evaluation of medical plants in Jordan and possible exploitation benefits to local communities. Annually I supervise several master degree students in regulatory affairs as well as pharmaceutical IPR.
- MANAGERIAL COOPERATION:
I have managed tasks such as law related to pharmaceutical regulation and in particular to regulatory requirements. I have participated in drafting pharmaceutical IPR in developing countries. In this regard I have worked with well-known characters in the field such as:
- Heinz Goddar – Former President LES; Boehmert & Boehmert, Munich, Germany.
- Mohammed Al Sharif – UNDP Bahrain office.
- Majed Al Rufayyiq – GCC patent office, Saudi Arabia.
- Lina Zeinal – Bahrain Patent office.
- Khalid Arabyat – Jordan Industrial property directorate, MIT.
- Konstantinos Karachalios (EPO)
- Pascal Phlix – Project for Africa & the Middle East (EPO)
- Harald Pichlhofer – Head of Unit Institutional Strengthening European Patent Academy (EPO)
- Josef Riolo – Member of a Board of Appeal in Chemistry (EPO)
For regulatory affairs and other related pharmaceutical matters I have worked with well-known professionals in the field such as:
- Dr Christa Wirthumer-Hoche AGES Austria
- Peter Bachmann BfARm Germany
- Mohammed Al-Haidari SGH of GCC central registration
- Saleh Al-Tayyar SFDA Saudi
- Saleh Bawazeer SFDA Saudi
- Hanan Laithy ex-EDA head, Egypt MOH
- Salah Mawajdah – ex-President of Jordan food & Drug Administration (JFDA) & EX- Minister of health currently (2007)
- Adnan Badwan – Head of Jordan Chamber of Industry and head of Arab Union of the Manufacturers of Pharmaceutical & Medical application (AUPAM).
1. General Director of SIPS. SIPS is pharmaceutical consultancy company. SIPS provide studies to various private and public center establishment such as:
- SIPS is professional regulatory affairs consultancy and CRO.
- SIPS is responsible for IPR in client pharmaceutical companies.
- SIPS is represented in the ministry of health IP forum.
- SIPS cooperate closely with Ministry of trade and industry on pharmaceutical industry issues.
Finally while SIPS is private organization it positioned itself to be an extension of public sector to enforce and promote pharmaceutical innovation.
2. Senior advisor; Industrial Investment Council (IIC), German government organization, Berlin, Germany.
3. Arab Union of the Manufacturers of Pharmaceuticals & Medical Appliances (AUPAM) pharmaceutical IPR and technical consultant.
4. Headed IPR committee at ministry of health, Jordan.
5. UNDP 2006 thematic expert on pharmaceutical IPR in Bahrain kingdom project.
The main areas of interest are pharmaceutical innovation and related Intellectual Property Rights with focus on Patents and Secret Know-how. Further my main expertise and input is centred on CMC aspects of product development. In this regard I have participated in the following activities as expert speaker:
1. Ministry of Trade symposium on “Effect of Joining the WTO on the Arab Pharmaceutical Industry”, – (1996).
2. WIPO symposium on “Intellectual Property Laws and the Pharmaceutical Industry”, – (1996).
3. JUMP symposium “Patent Law Effect on the Prospects of the Pharmaceutical Industry” – Amman, Jordan (1999).
4. JUMP symposium “Effects of proposed Jordanian F.P laws on local Pharmaceutical law” – Amman, Jordan (1999).
5. Working conference on “the future of the Pharmaceutical Industry into the 21 century” – London, UK (1999).
6. WIPO symposium “Intellectual Property overview” – Amman, Jordan (2000).
7. E.U workshop “European Partnership agreement and the rules of origin” – Amman, Jordan (2000).
8. E.U workshop “European Partnership agreement and TRIPS” – Amman, Jordan (2000).
9. Royal Pharmaceutical society symposium “Recent trends in use law relating to Pharmaceutical Industry” – London, UK (2000).
10. Boehmert & Boehmert Training seminar on Obtaining, Enforcing and Evaluating IP R in Europe – Munich, Germany (2002).
11. Patent Profile for Product Choice – Amman (2002)
12. Pharmaceutical Patents Search, Reading and Analysis – Amman, Jordan ( 2002)
15. LES-Italy, Europe Health Care conference – Milan (2002).
16. Boehmert & Boehmert Training seminar on Obtaining, Enforcing and Evaluating IP R in Europe – Munich, Germany (2003).
17. Boehmert & Boehmert Training seminar on Obtaining, Enforcing and Evaluating IP R in Europe – Munich, Germany (2004).
18. EPO-WIPO seminar International IP agreement & negotiations – Geneva, Switzerland (2004)
19. Boehmert & Boehmert Training seminar on Obtaining, Enforcing and Evaluating IP R in Europe – Munich, Germany (2005).
20. EPO-WIPO seminar International IP agreement & negotiations – Geneva, Switzerland (2005).
21. Globalization challenges to Arab pharma – Aleppo/ Syria (2006).
22. Towards Pharmaceutical IP Expert -Amman/Jordan (2006).
23. Boehmert & Boehmert Training seminar on Obtaining, Enforcing and Evaluating IP R in Europe – Munich, Germany (2006).
24. IPRs & their impacts on Chemical, Pharmaceutical & Bio-pharmaceutical industries – Iran (2006).
25. Boehmert & Boehmert Training seminar on Obtaining, Enforcing and Evaluating IP R in Europe – Munich, Germany (2007).
26. Pharma IP Conference – Riyadh/ Saudi Arabia (2007).
27. Unified Drug Dossier – Jeddah/ Saudi Arabia (2007).
28. EPO academy “Recent developments on Patent Related IP law” – Munich, Germany (2007).
29. Boehmert & Boehmert Training seminar on Obtaining, Enforcing and Evaluating IP R in Europe – Munich, Germany (2008).
30. Dossier requirements – including new Global Quality initiatives – Amman/Jordan (2008)
31. Generic pharmaceutical drug registration & IP – Muscat/Oman (2008).
32. Market Authorization in the Middle East – Munich/ Germany (2008).
33. Market Authorization in the Middle East – Frankfurt/ Germany (2009).
34. Conservation of Medicinal and Herbal Plants of Jordan – Dead Sea/Jordan (2009).
35. Market Authorization in the Middle East – Frankfurt/ Germany (2010).
36. Globalization of Arabian pharmaceutical industry to meet the challenges of the agreement on TRIPs – Sharm El Sheikh/Egypt (2010).
37. Marketing Authorization strategies for global submission – Frankfurt/ Germany (2010).
38. CTD/eCTD the challenge & success seminar – Cairo/Egypt (2010).
39. Market Authorization in the Middle East – Frankfurt/ Germany (2010).
40. Global submissions– Frankfurt/ Germany (2011).
41. National Day for Generic drug – Algeria/Algeria (2011)
42. Pharmaceutical & Medical Equipment business Development congress – Beirut/Lebanon (2011)
43. Participate in creating Arab Harmonization for Medical Devices (AHMD) (2011)
44. Market Authorization in the Middle East – Frankfurt/ Germany (2011).
45. Pharmacovigilance in Middle East Conference – Abu Dhabi/UAE (2012).
46. Marketing authorization in the Middle East, Africa, Turkey, Australia and New Zealand – Frankfurt/Germany (2012)
47. Medical devices: Marketing authorization in the Middle East & North Africa (MENA) – Mannheim/Germany (2012).
48. Visionary Innovators – Riyadh/KSA (2012).
49. Good pharmacy practice – Cairo/Egypt (2012).
50. Osteocerein 2nd anniversary symposium – Novartis, Alexandria/Egypt (2012).
51. The protection of invention in the pharmaceutical sector: Patent, Undisclosed information & Health policies – Riyadh/KSA (2012)
52. Lecturer in regulatory affairs of pharmaceutical products & market authorization diploma with The University of Jordan, Centre of Consultations 2010 until now.
53. Oman is an Attractive Environment for Pharmaceutical Investment, Pharmacoeconomics conference, SIPS & Oman Pharmacist Society, Muscat, Oman (Nov. 2014).
54. Marketing authorization in the Middle East – Forum Institute, Frankfurt/Germany 2013 until now.
55. Pharmacovigilance in the Middle East Diploma, Forum Institute, Frankfurt/Germany (2018)
56. CMS requirements EU vs. MENA, SIPS & FORUM Institute, Dubai (2018).
1. Supervised & managed legal compliance of DMF delivery process to SFDA on behalf of clients (2016).
2. Performed legal intelligence on Indian API suppliers use of diacerein secret information to Egypt MOH (2016).
3. On the Supervisory Board of Regulatory Affair Vocational Diploma since April 2010 until now.
4. Review exist IPR policies related to medicinal herbs & write new policy & Guideline for medicinal herbs in Jordan (pharmaceutical, cosmetic & food) 2009.
5. Accredited Arbitrator in GCC Commercial Arbitration Center.
6. Jordan IP regulation in health drafting system & regulation during 2003 – 2005.
7. Revising reading of Jordan patents of Invention law No. (32) of 1999.
8. Submission of complaints & contradiction of Jordan patents of Invention law No. (32) of 1999 for minister of Industry & Trade.
9. Reviewing Jordan PCT law requirement & regulation through propose patent law change for the year 2006.
10. Proposal for adapting European patent Convention EPC to Middle East countries patent laws submitted to the EPO, Middle East & North African region.
11. Implementing international agreement obligation into developing countries patent system draft proposal for discussion with WIPO/EPO – Geneva, Switzerland (2005).
12. Regulations of implementing Jordan Trademarks Law No. (33) of 1952 in view of generic industry use of originators compound name submitted for Ministry of Industry & Trade – Jordan (2005).
1. Senior advisor to AUPAM on technical issues, Amman, Jordan, 2008 – 2018.
2. On the Supervisory Board of Regulatory Affair Vocational Diploma since April 2010 until now.
3. Head of LES –AC “Pharmaceutical Sciences committee” years 2005 until now.
4. Review & write new standards for medicinal herb (pharmaceutical, cosmetic & food) 2009.
5. Review & edit PHARMACEUTICAL INTELLECTUAL PROPERTY from INNOVATORS to GENERICS book 2009.
6. Qualified Expert in GCC Commercial Arbitration Centre, Pharmaceutical group, Bahrain.
7. Senior advisor on life science for Industrial Investment Council – Germany years 2003-2008.
8. Member National committee on Quality Control of Herbal Laboratory, Ministry of Planning years 2005 until 2006.
9. Review & edit EPC practical guide book in Arabic 2004.
10. Member of the Technical board of review in the Jordan FDA years 2000 until 2005.
Partial list for view of scientific expertise.
1. MMM Saleem (2017) AUPAM annual conference, Cairo, Egypt. “From API to FP: quality integrity and PV”.
2. MMM Saleem (2016) AUPAM annual conference, Amman, Jordan. “Serialization and PV standards in MENA”.
3. MMM Saleem (2015) Roche and cancer society, Cairo, Egypt. “MAP production impact on quality”.
4. MMM Saleem (2015) eRA annual conference, Sharm Elsheikh, Egypt. “MENA eCTD implementation road map”.
5. MMM Saleem (2014) Roche and cancer society, Alexanderia, Egypt. “Biopharmaceutical production impact on quality”.
6. MMM Saleem (2012) AUPAM annual conference, Amman, Jordan. “CTD standards with focus on module 3”.
7. MMM Saleem (2010) AUPAM annual conference, Cairo, Egypt. “CMC harmonization with EU”.
8. MMM Saleem (2008) speaker and panel head with Dr Saleh Bawazeer (SFDA), Dr Christa Wirthumer-Hoche (AGES), Dr Mohammed Rabaie (Oman MOH), Dr Nadia Younis (UAE MOH), Dr Samia Salah (Egypt EDA MOH). “CMC requirements in MENA compared to EU requirements”.
9. MMM Saleem (2007) Ministry of Industry Report, Bahrain, UNDP report “untilization of palm tree pollen as pharmaceutical preparation”.
10. MMM Saleem (2003-2007) speaker in Annual training program for innovation in pharmaceutical products, Amman, Jordan.
11. MMM Saleem (2003) Annual Arab Unioin Pharmaraceutical Manufacturers conference, Amman, Jordan. “Strategy for innovation in pharmaceutical formulation.
12. MMM Saleem (2002), Jordan Pharmaceutical Association, “IPR”.
13. MMM Saleem (2002), Arabian Gulf University Convenes the Arab conference on Medicinal Plants, “Patent and Related Rights in Herbal Preparations”, pp7.
14. MMM Saleem, TS El-Taher, S. Khatib, A. Shnoudeh, AA. Badwan. )2002(, International Journal of Impotence Research, “A novel compound JPM8, in vivo penile activity promotion in rats, effect on the relaxation and cGMP/cAMP accumulation in isolated rabbit corpora cavernosa” pp453-461.
15. MMM Saleem (2002), Utilization Of Computer Authoring systems in educational establishments pp 152-160.
16. MMM Saleem, K. Matalka, T. Elthaher, T. Arafat, A. Jehanli & A. Badwan (2001) “An enzyme Linked immuosorbent assay for determination of amlodepination of amlodpine in plasem” J. Clin. Lab. Anal. 14.
17. MMM Saleem (2000) “patent law in pharmaceuticals: comparative study of Jordanian law referenced to EPC” ACDIMA conference on Effects of WTO on the future of the Arab Pharmaceutical industries”, Tunisia 20-23.
18. MMM Saleem, M. Albarghouthi, D. AbuFaram, T. Elthaher, K. Matalka & A. Badwan (2000) “Immobilization of antibodies on alginate-chitosan beads” Int. J. Pharm. 206, 23-34.
19. MMM Saleem “Utilization pf I.P. Laws for the local Pharmaceutical industry”, “Proceedings of ninth Jordanian Pharmaceutical union conference” P.35, 2000.
20. MMM Saleem 2000 African Conference on Medicinal Plants Research, Quality of Raw Material in Herbal Medicine Preparations pp 6.
21. MMM Saleem and H.Taha “Quality of raw material in Herbal medicine preparations”, “Proceedings of ninth Jordanian Pharmaceutical union conference” p.35, 2000.
22. M.Saleem and H.Taha “International comparative study on market authorization of medical herbal products” Herbal medical conference Libya, 1999.
23. MMM Saleem and H.Taha “Regulations governing market authorization of medical herbal products” Herbal medicine conference Jordan, 1998.
24. MMM Saleem (1997) “Simulation an effective training tool”, Pharmaceutical industry J. 1,25-29.
25. MMM Saleem (1997) “stability of recombinant protein drugs” Arab Union of Pharmaceutical manufactures conference, “Pharmaceutical Biotechnology”.
26. MMM Saleem “Molecular modelling of Keterolac tromthamine aqueous solubilization of hydrophobic compounds” Biotechnology symposium, 1996, Jordan. P 17.
27. MMM Saleem “NMR simulation by computers” UNESCO: workshop on modern trends in chemistry, Egypt, 1994.
28. MMM Saleem “Evaluation of CAL on educational objectives” International Symposium on CAL 11-14 April 1989, Th/1645/P/G, university of Surry, U.K.
29. MMM Saleem & MT Wilson (1989), “Kinetic Studies on the Reduction of Cytochrome C. Reaction with Thiolic Compounds” Unpublished results.
30. MMM Saleem & M. T. Wilson (1988), “Ligand Binding to Cytochrome c and other related Haem Proteins and Peptides. Part III. Temperature Dependence Studies.” Inorganica chimica Acta153, pp105-113.
31. MMM Saleem & M. T. Wilson (1988), “Ligand Binding to Cytochrome c and other related Haem Proteins and Peptides. Part II. Kinetic Studies.” Inorganica chimica Acta153, pp99-104.
32. MMM Saleem & M. T. Wilson, “Ligand Binding to Cytochrome c and other related Haem Proteins and Peptides. Part I. Equilibrium Studies.” Inorganica chimica Acta153(1988), pp93-98
33. MMM Saleem & MT Wilson (1988) Inorg chem. Acta 153, 105 “III Temperature Dependence Studies”.
34. MMM Saleem & MT Wilson (1988) Inorg chem. Acta 153, 99 “II Kinetic Studies”.
35. MMM Saleem & MT Wilson (1988) Inorg chem. Acta 153, 93 “Ligand binding to Haem Proteins. I Equilibrium Studies”.
36. MMM Saleem, AL-Kharafi, & A Hajaj (1987) “UNESCO-SEFI International Symposium on Innovative Methods in Technological Education” Orsay-France 21-24 September pp448-458 “Perspectives of Computer Education in Kuwait”
37. MMM Saleem (1987) “UNESCO-SEFI International Symposium on Innovative Methods in Technological Education” Orsay- France 21-24 September pp 152-160 “Utilization of Computer Authoring Systems”.
38. MMM Saleem & MT Wilson (1987) Inorg Chem. Acta 137, 139 “Kinetic Studies on the Reduction of Cytochrome C- Reaction with Organic Oxy – Compounds”.
39. MMM Saleem, Jim Peterson, Jack silver, Michael T. Wilson& Ian E. G. Morrison (1983)” On the Preparation and Mossabauer Properties of Some Heme Peptides of Cytochrome C” Journal of Inorganic Biochemistry19, pp165-178.
40. MMM Saleem & MT Wilson (1982) Biochem J 201, 433 “Reduction of Cytochrome C and other Heam Proteins by Catechol(s) and Quinol(s)”.