Paul Larocque
Specialties: Manufacturing
Biography
Paul Larocque is the President of Acerna Inc., a pharmaceutical, biological and medical device consultancy which provides good manufacturing practice and regulatory affairs services to a global clientele. For the past twelve years as a consultant, and previously in industry, Paul's focus was FDA compliance matters.
Previously, Paul held executive positions related to sterile products with Pfizer, SmithKline/Allergan and Eldan Pharmaceuticals. He also headed the unit responsible for the review of the chemistry and manufacturing parts of drug submissions at Health Canada. In addition, he chaired the industry committee that negotiated the sterile products chapter of GMP regulations at Health Canada.
He received his Bachelor of Science degree in Chemistry from the University of Ottawa. Mr. Larocque is a Chartered Chemist in Ontario, a Member of the Chemical Institute of Canada and was chosen for the Governor General's Study Group.
He was named a Fellow of The Organization for Professionals in Regulatory Affairs in Europe and has served on several trade association boards or committees; including a Chairmanship on the committee which negotiated Canadian GMP Guidelines. Mr. Larocque has twice been elected Chair of the Canadian Association of Professionals in Regulatory Affairs.
Publications
1. Larocque, Paul J., The NOC – The News of Course magazine, Fall 2017, CAPRA – Canadian Association of Professionals in Regulatory Affairs.
2. Larocque, Paul J.: Maple Leaf News, Regulatory Rapporteur, page 8, Nov 2017, Journal for Professionals in Regulatory Affairs, Vol. 14, No. 11.
3. Larocque, Paul J., Pharmaceutical Online, 2017-02-20, Which Test is Appropriate for Container-Closure Integrity?
4. Larocque, Paul J., PDA Letter, Oct. 2016, p. 17, Which Test is Appropriate for Container-Closure Integrity?
5. Larocque, Paul J.: Maple Leaf News, Regulatory Rapporteur, page 26, May 2016, Journal for Professionals in Regulatory Affairs, Vol. 13, No. 5.
6. Larocque, Paul J., Macelans.ca, 2016-02-25, Ottawa
7. Larocque, Paul J., PDA Letter, June 2015, p. 20, Inconsistent Expectations Clash with Industry Best Practices for Sterile Products.
8. Larocque, Paul J., National Post, 2015-04-21, p. A11, letter.
9. Larocque, Paul J.: Maple Leaf News, Regulatory Rapporteur, page 22, April 2015, Journal for Professionals in Regulatory Affairs, Vol. 12, No. 4.
10. Larocque, Paul J., Macleans, 2015-01-12, p.6, letter.
11. Larocque, Paul J., Macleans, 2014-03-03, p.6, letter.
12. Larocque, Paul J.: Maple Leaf News, Regulatory Rapporteur, page 32, Feb. 2014, Journal for Professionals in Regulatory Affairs, Vol. 11, No. 2.
13. Larocque, Paul J., Markham Economist & Sun, letter, 27th Feb 2014, p. 6.
14. Larocque, Paul J.: Aspects on the harmonisation agenda, Regulatory Rapporteur, page 27, February 2013, The International Journal for Professionals in Regulatory Affairs, Vol. 10, No. 2.
15. Larocque, Paul: Maple Leaf News, Regulatory Rapporteur, page 28, October 2012, The International Journal for Professionals in Regulatory Affairs, Vol. 9, No. 10.
16. Larocque, Paul: Canadian Business, Investor 500, Summer (May) 2012, p. 6.
17. Larocque, Paul: Maple Leaf News, Regulatory Rapporteur, page 29, January 2012, The International Journal for Professionals in Regulatory Affairs, Vol. 9, No. 1.
18. Larocque, Paul: Canadian Business, 2011-10-10, p. 6.
19. Larocque, Paul: Maple Leaf News, Regulatory Rapporteur, page 21, September 2011, Journal for Professionals in Regulatory Affairs, Vol. 8, No. 9.
20. Larocque, Paul: Maple Leaf News, Regulatory Rapporteur, page 25, September 2010, Journal for Professionals in Regulatory Affairs, Vol. 7, No. 9.
21. Larocque, Paul: Leveling the compliance playing field, Pharmaceutical Technology, p. 70, June 2010, Vol. 34, No. 6.
22. Larocque, Paul: Maple Leaf News – Canada, Regulatory Rapporteur, page 27, June 2010, Journal for Professionals in Regulatory Affairs, Vol. 7, No. 6.
23. Larocque, Paul: Good Review Practise – Canada, Regulatory Rapporteur, page 24, Jan. 2010, Journal for Professionals in Regulatory Affairs, Vol. 7, No. 1.
24. Larocque, Paul: Maple Leaf News, Regulatory Rapporteur, page 25, September 2009, Journal for Professionals in Regulatory Affairs, Vol. 6, No. 9.
25. Larocque, Paul: Maple Leaf News, Regulatory Rapporteur, page 25, April. 2009, Journal for Professionals in Regulatory Affairs, Vol. 6, No. 4.
26. Larocque, Paul, et al.: interview with Garrett, Monique and Warner, Julie: Regulatory Rapporteur, page 17, Mar. 2009, Journal for Professionals in Regulatory Affairs, Vol. 6, No. 3.
27. Larocque, Paul: Maple Leaf News, Regulatory Rapporteur, page 30, Feb. 2009, Journal for Professionals in Regulatory Affairs, Vol. 6, No. 2.
28. Larocque, Paul: Maple Leaf News, Regulatory Rapporteur, page 28, Sept. 2008, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 5, No. 9.
29. Larocque, Paul: Maple Leaf News, Regulatory Rapporteur, page 24, April 2008, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 5, No. 4.
30. Larocque, Paul: Maple Leaf News, Regulatory Rapporteur, page 16, January 2008, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 5, No. 1.
31. Larocque, Paul: Maple Leaf News, Regulatory Rapporteur, page 25, September 2007, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 4, No. 9.
32. Larocque, Paul: Maple Leaf News – Update from Canada. Regulatory Rapporteur, page 24, April 2007, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 4, No. 4.
33. Larocque, Paul: Maple Leaf News – Update from Canada. Regulatory Rapporteur, page 24, January 2007, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 4, No. 1.
34. Larocque, Paul: Complementary Medicine, Canada: Natural Health Product regulation. Regulatory Rapporteur, page 18, July/August 2006, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 3, No. 7/8.
35. Larocque, Paul: Maple Leaf News – Update from Canada. Regulatory Rapporteur, page 29, April 2006, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 3, No. 4.
36. Larocque, Paul: Maple Leaf News – Update from Canada. Regulatory Rapporteur, page 26, January 2006, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 3, No. 1.
37. Larocque, Paul: What Incorporation Means for you, The News of Course, The N.O.C., 63, Winter 2005, Canadian Association of Professionals in Regulatory Affairs – Association canadienne des professionnels en réglementation
38. Larocque, Paul: Maple Leaf News – Update from Canada. Regulatory Rapporteur, page 31, September 2005, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 2, No. 9.
39. Larocque, Paul: Maple Leaf News – Update from Canada. Regulatory Rapporteur, page 26, January 2005, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 2, No. 1.
40. Larocque, Paul: Maple Leaf News – Update from Canada. Regulatory Rapporteur, page 19, July 2004, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 1, No. 7.
41. Larocque, Paul: Maple Leaf News – Update from Canada. Regulatory Rapporteur, page 23, April 2004, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 1, No. 4.
42. Larocque, Paul: Maple Leaf News – Update from Canada. Regulatory Rapporteur, page 33, January 2004, Journal of The Organization for Professionals in Regulatory Affairs, Vol. 1, No. 1.
43. Larocque, Paul: Maple Leaf News – Update from Canada. ESRA Rapporteur, page 18, September/October 2003, Journal of the European Society of Regulatory Affairs, Vol. 10, No. 5.
44. Larocque, Paul: Maple Leaf News – Update from Canada. ESRA Rapporteur, page 23, May/June 2003, Journal of the European Society of Regulatory Affairs, Vol. 10, No. 3.
45. Larocque, Paul: Maple Leaf News – Update from Canada. ESRA Rapporteur, page 16, January/February 2003, Journal of the European Society of Regulatory Affairs, Vol. 10, No. 1.
46. Larocque, Paul: Guideline Review: Active Pharmaceutical Ingredients – ICH Guideline Q7A, The News of Course, The N.O.C., 57: 10, January 2003, Canadian Association of Professionals in Regulatory Affairs – Association canadienne des professionnels en réglementation
47. Larocque, Paul: Maple Leaf News – Update from Canada. ESRA Rapporteur, page 26, November/December 2002, Journal of the European Society of Regulatory Affairs, Vol. 9, No. 6.
48. Larocque, Paul: Maple Leaf News – Update from Canada. ESRA Rapporteur, page 9, March/April 2002, Journal of the European Society of Regulatory Affairs, Vol. 9, No. 2
49. Larocque, Paul: Executive Director’s Message The News of Course, The N.O.C., 52: 2, October 2001, Canadian Association of Professionals in Regulatory Affairs – Association canadienne des professionnels en réglementatio
50. Larocque, Paul: Canadian Association of Professionals in Regulatory Affairs – Association canadienne des professionnels en réglementation, ESRA Rapporteur, July/August 2001, page 26, Journal of the European Society of Regulatory Affairs, Vol. 8, No. 4.
51. Larocque, Paul: Canadian Update, ESRA Rapporteur, July/August 2001, page 24, Journal of the European Society of Regulatory Affairs, Vol. 8, No. 4.
52. Larocque, Paul: Vox Populi. The News of Course, The N.O.C., 50: 2, April 2001, Canadian Association of Professionals in Regulatory Affairs – Association canadienne des professionnels en réglementation
53. Larocque, Paul: Patents: Why 17 Years? (reprint #13) ESRA Rapporteur, March/April 2001, page 25, Journal of the European Society of Regulatory Affairs, Vol. 8, No. 2.
54. Larocque, Paul: Patents: Why 17 Years? The News of Course, The N.O.C., p. 4, September 2000, Canadian Association of Professionals in Regulatory Affairs – Association canadienne des professionnels en réglementation
55. Larocque, Paul: Looking Forward, The News of Course, The N.O.C., page 3, January 2000, Canadian Association of Professionals in Regulatory Affairs – Association canadienne des professionnels en réglementation
56. International Pharmaceutical Academy /Out-of-Specification Investigations Conference (Speaker) 1999-10
57. Larocque, Paul: Establishment Licensing re Bureau of Pharmaceutical Quality – S. Ghani & T. Burke presentation. The News of Course, The N.O.C. p. 5, April 1999, Canadian Association of Professionals in Regulatory Affairs – Association canadienne des professionnels en réglementation
58. Larocque, Paul: Division of Pharmaceutical Quality – Andrew Adams’ presentation. The News of Course, The N.O.C. p. 3, January 1999, Canadian Association of Professionals in Regulatory Affairs – Association canadienne des professionnels en réglementation
59. Larocque, Paul: Submission Control: The Queue, The News of Course, The N.O.C., page 3, December 1997, Canadian Association of Professionals in Regulatory Affairs - Association canadienne des professionnels en réglementation
60. Larocque, Paul: Regulatory and Civil Liability for Labelling – P. Bonner presentation. The News of Course, The N.O.C. p. 5, December 1996, Canadian Association of Professionals in Regulatory Affairs - Association canadienne des professionnels en réglementation
61. Larocque, Paul: Drug Inspection Strategy – J-M. Charron presentation. The News of Course, The N.O.C. p. 1, September 1996, Canadian Association of Professionals in Regulatory Affairs - Association canadienne des professionnels en réglementation
62. Larocque, Paul: Software to Draw Chemical Structures – Logiciel servant à illustrer des structures chimiques. Chemputing, Canadian Chemical News – L’Actualité chimique canadienne 48: 4, 1996
63. Larocque, Paul: Cost Recovery. The News of Course, The N.O.C., p. 7, Autumn 1995, Canadian Association of Professionals in Regulatory Affairs - Association canadienne des professionnels en réglementation
64. Larocque, Paul: Comprehensive Summary of Chemistry and Manufacturing re Bureau of Pharmaceutical Quality – M. Ward presentation. The News of Course, The N.O.C., p. 1, Autumn 1995, Canadian Association of Professionals in Regulatory Affairs - Association canadienne des professionnels en réglementation
65. Larocque, Paul: Purified Water Systems, presented to the (Rx&D) Pharmaceutical Manufacturers Association of Canada – Plant Operations Section conference, 1988